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ISPO Report 1

Lower Limb Amputations Due to Vascular Disease: A 2

Multidisciplinary Approach to Surgery and Rehabilitation 3

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Karen L. Andrews; Malte Bellmann; Helena Burger; 5

Joseph Czerniecki; Bernard Greitemann; Jan H. B. 6

Geertzen; Andreas Hahn; Matthew Houdek; Anton 7

Johannesson; Gert-Uno Larsson; Magnus Lilja; Saffran 8

Moeller; Carolina Schiappacasse; Ernst Schrier; Harmen 9

van der Linde; Harry Voesten; Saeed Zahedi 10

11 INTRODUCTION 12

Vascular disease is the most common cause of amputation, accounting for 82% of all 13

amputations.1 Although the incidence of amputations due to trauma and cancer has 14 decreased,1, 2 amputation due to vascular disease continues to increase. In this report, we 15 discuss the evaluation and management of peripheral arterial disease (PAD); limb salvage; 16

amputation and amputation surgery; early management and prosthetic rehabilitation 17 following amputation due to vascular disease. Assessment by a multidisciplinary team in the 18

preoperative phase forms the basis for the policies to be followed after surgery and during the 19 rehabilitation process. The involvement of multiple disciplines reduces the risk of 20

complications during surgery and the postoperative phase.3 21 22

This ISPO consensus report is realized thanks to ISPO International, Otto Bock, Protheor, 23 Ossur, and Blatchford with the engagement and cooperation of the members of the ISPO 24 consensus meeting February 2015, Basingstoke, UK. A Dutch guideline on amputations and 25 prosthetic rehabilitation due to vascular disease was published in 2012. Over the past five 26

years, additional relevant papers regarding management of lower limb amputation due to 27 vascular disease have been published. The ISPO International Consensus Group comprised of 28 academicians, clinicians, and researchers was chosen to update the 2012 guidelines. The 29 composition of the Consensus Group was based on profession, region of the world, and 30 expertise. Members included orthopaedic surgeons, rehabilitation physicians, prosthetists, 31

therapists, and engineers all with expertise in amputation surgery and prosthetic rehabilitation. 32 The goal of this report is to provide an updated version of the previous guidelines. This report 33

is created for care providers throughout the world who are involved in the care of people with 34 lower limb amputation due to vascular disease. Resources and expertise differ widely in many 35 parts of the world. We hope that updating the Dutch guidelines to create an international 36 report will help nations establish their own guidelines. 37 38

METHODS 39 DATA SOURCES AND SEARCHES 40 In 2012, the Netherlands Society of Physical and Rehabilitation Medicine (VRA), a national 41 society for medical specialists in rehabilitation medicine, and the Utrecht-Based Dutch 42

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Institute for Healthcare Improvement (CBO) developed the Dutch Guidelines for amputation 43 and prosthetics of the lower extremities. 44

45 The recommendations in the 2012 Dutch guidelines were based on evidence from published 46 scientific research. Relevant articles were identified by performing systematic searches in the 47 Cochrane Library, Medline, Embase, PsycINFO and CINAHL. Languages were limited to 48 Dutch, English, German, and French. Manual searches were also conducted. Search dates were 49

between 1966 (Medline) or 1980 (Embase) and early 2009 and no later than January 2011. 50 51 The current report was developed by a consensus process and is based on additional relevant 52 references found through a consensus meeting February 2015, in Basingstoke, UK. We sought 53 to capture the highest quality of literature available regarding lower limb amputation due to 54

vascular disease. The text was reviewed and revised by the consensus group. We formulated 55

updated recommendations of key points for daily practice based both on available evidence and 56 expert opinion. 57

58 The report underwent a Delphi Consensus among the panel members. The first draft of this 59 guideline was presented in 2017 at the ISPO World Congress for public comment. Subsequent 60

drafts were revised based on those comments. 61

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EVALUATION OF THE PERSON WITH VASCULAR DISEASE PRIOR TO LOWER 63 LIMB AMPUTATION 64 65 Guideline #1.1: To prevent amputation, it is critical that patients with peripheral arterial 66 disease (PAD) at risk of amputation are detected at an early stage. This includes the 67 identification and treatment of circulatory disorders and wounds. 68

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Updated Evidence: In order to prevent amputation it is recommended that patients with critical 70 limb ischemia (chronic ischemic rest pain, ulcers, or gangrene) receive a multidisciplinary 71 evaluation and treatment (including surgeon, interventional radiologist, vascular internist, 72

rehabilitation physician, anaesthesiologist, pain specialist and physiotherapist, with the possible 73

additional involvement of an orthopaedic technician or prosthetist). (Dutch Guideline Diabetic 74 Foot 2006) 75 76 Prior to amputation, the medical comorbidities and vascular status (perfusion of the limb) 77 should be assessed. The first step to evaluate the vascular status involves physical examination 78

including pulse exam and assessing the degree of ischemia 79 80 The working group recommends that all diabetic patients with ulcers be assessed for PAD 81

using objective tests, such as duplex ultrasound and ankle-brachial indices. In patients with 82 peripheral arterial disease and diabetes, claudication may be masked due to neuropathy. The 83 use of transcutaneous oxygen pressure (TcPO2) may provide an important tool to make clinical 84

decisions regarding an appropriate level of amputation.4 85

86 Guideline #1.2: Where arterial imaging is necessary for treatment decisions, the following 87 imaging techniques are recommended: duplex examination, DSA, MRA and CTA. If the 88 vascular status is not yet established or if demarcation of the region for amputation has not yet 89

taken place, it is advisable to postpone amputation. 90

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91 Updated Evidence: Arterial disease can be demonstrated by either non-invasive or invasive 92

vascular tests. The vascular laboratory plays an important role in non-invasive studies. 93 94 In addition to the clinical assessment, anatomic localization of vascular disease can be obtained 95 with segmental blood pressure or pulse volume recordings. Arterial calcification may result in 96 non-compressible vessels with the inability to obtain ankle brachial indices (ABIs). The ABI is 97

not accurate when the systolic blood pressure cannot be abolished using a blood pressure cuff. 98 The incidence of non-compressible (artifactually high), calcified conduit arteries is highest in 99 diabetic, elderly, and chronic renal failure patients. The resulting ABI values can be falsely 100 elevated. Despite high recorded systolic pressure, these individuals may have severe disease. 101 In this population, a greater importance should be attached to toe pressures and TcPO2 102

measurements.5 103

104 In a randomized controlled trial (RCT), the influence of ischemia treatment decisions in 105

relation to revascularisation on the basis of the clinical picture and ankle-brachial index was 106 compared with the decision to treat on the basis of TcPO2 and toe pressure measurements. 107 TcPO2 and toe pressure measurement did not improve the clinical outcome, but determination 108

can be helpful in case of doubt regarding the need for revascularisation.5 109 110 When a discrepancy between clinical findings and non-invasive vascular studies arises, 111

vascular imaging should be considered.6 112 113

Guideline #1.3: When a patient has multiple medical comorbidities and is unable to undergo a 114 planned revascularization procedure or when it is unlikely that restoration of circulation will 115 lead to a functional limb, initial amputation should be considered. 116

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Updated Evidence: Revascularisation (surgical or endovascular) are effective in the prevention 118 of amputation. (Dutch guideline vascular disease 2005). Because evidence indicates that blood 119 flow to the lower limb improves in the first three weeks after revascularisation, deferred 120

amputation following revascularisation is preferred.7 An amputation should be performed 121

when a subsequent vascular reconstruction is no longer possible or if, despite successful 122 revascularization, progressive ischemia is noted. 123 124 When revascularization is not an option or revascularization will not result in a functional limb, 125 amputation should be considered. Amputation, rather than revascularisation, may offer 126

patients a more rapid return to an acceptable quality of life. 127 128 The European Consensus document defines CLI as persistently recurring ischemic rest pain or 129

ulceration, or gangrene of a foot or toes lasting greater than two weeks.8 130

According to TASC II6 the following indicate critical limb ischemia: 131

Ankle pressure < 50 mm Hg 132

Toe pressure < 30 mm Hg 133

TcPO2 < 30 mmHg 134 It is estimated that 5%-10% of patients with peripheral arterial disease older than 50 years 135

develop CLI within five years.9 136

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In a study looking at the costs of management of CLI looking at wound healing, functional 137 outcomes, quality adjusted life years (QALY), and cost, surgical revascularization was the most 138

cost effective alternative to local wound care alone for patients with critical limb ischemia with 139

tissue loss.10 140

Critical limb ischemia (CLI) may be an indication for amputation in patients with PAD. Early 141 amputation may be indicated in critical limb ischemia, with the aim of achieving a better long-142 term function and a lower risk of comorbidity.11, 12 143 144 Decision-making regarding limb salvage versus amputation remains complex and is best made 145

by the consensus of surgical and rehabilitation subspecialities. Evidence suggests that there is 146 no significant difference in outcomes at two years when comparing revascularization versus 147 amputation, although limb salvage is associated with higher risk of complications, additional 148 surgeries, and re-hospitalizations.13 149

150 An important question is to determine which subgroups of patients with critical limb ischemia 151 would ultimately benefit more from an amputation than from revascularisation. For example, 152

in ambulatory older individuals, extensive revascularization surgery may result in reduced 153 mobility. Instead, an initial amputation could be considered a viable treatment option with 154 improved mobility and quality of life.14 Technical factors, aspects of wound healing, 155 deconditioning and existing comorbidities are all factors that determine whether a patient is 156

suitable for amputation. 157 158

Critical limb ischemia is associated with high morbidity and mortality. Evaluating 13 studies 159

enrolling 1,527 patients with a median follow up of 12 months, all-cause mortality was 22% and 160

major amputation rate was 22%.15 161

30% of patients with CLI require amputation within the first year after diagnosis. The five-year 162

mortality rate for CLI patients is 70% and most of those deaths are cardiovascular related.9 163

Revascularization is more expensive and less beneficial in the end stage renal disease (ESRD) 164 patient population than in the general CLI population.16 Two characteristics of the end stage 165 renal disease patient population make attempts at limb preservation through revascularization 166 and subsequent wound healing very challenging (1) limb salvage attempts fail more frequently in 167

the ESRD population than in non-ESRD critical limb ischemia; (2) the perioperative survival 168 rate and the long-term survival rate of patients with ESRD are both significantly lower than those 169

of the non-ESRD CLI population.17, 18 170

These challenges have led to some uncertainty about whether efforts to achieve limb 171 preservation are cost effective in the end-stage renal disease patient population. The current 172

analysis suggests that local wound care and endovascular intervention would be options that are 173 more cost effective than primary amputation.16, 19 174 175 An amputation is indicated if there is: a severe (life threatening) infection, tissue loss due to 176 extensive necrosis, intractable pain. Immediate amputation should be considered in cases of 177

acute ischemia and sepsis.6 178 179 In wet gangrene (whether local or generalised) immediate surgery is indicated to remove the 180 infection. A guillotine amputation can be used in this situation. A short period between 181

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diagnosis and amputation prevents further deterioration of the patient’s clinical condition, 182 resulting in an increased chance of recovery. In the stable phase following recovery from 183

sepsis syndrome, there will be an option for a subsequent definitive amputation. This leads to 184 better results than does a single intervention.20 185 186 Guideline #1.4: The purpose of an amputation is to achieve (initial) wound healing as distal as 187 possible with the highest possible post-amputation function.6 No clear criteria are given in the 188

literature for the clinical assessment of the amputation level.21 189 190 Updated Evidence: The level of amputation is determined by the clinical situation (degree of 191 ischemia, gangrene, pain, or infection) and the likelihood of successful initial wound healing. 192 It is important to evaluate patients’ comorbidities and mobility. In general more distal surgery 193

provides a better functional outcome, but has increased risk of non-healing, re-ulceration, and 194

re-amputation. Noninvasive arterial studies including TcPO2s or toe pressure measurements 195

may be useful to determine the optimal amputation level.9 196 197 Multidisciplinary evaluation and treatment (surgeon, anaesthesiologist, pain specialist, 198 rehabilitation physician, and vascular medicine specialist) is important for treatment of pain, 199

cardiovascular risks, comorbidities, and determine the level of amputation. The patient should 200

be seen in consultation with a rehabilitation physician preoperatively. 201 202 When an important decision like amputation needs to be made, the patient’s opinion should be 203

incorporated into the decision. Some patients may way the risks of a reduced rate of healing of 204 a distal amputation as acceptable if they have a higher likelihood of mobility. Others may 205

prefer a transtibial amputation where the probability of primary healing is better and mobility 206 may be adequate.22 207

208 The preservation of the patient’s knee has great advantages in terms of the chances of 209

becoming mobile. Every effort must be made to achieve initial wound healing and maintain the 210 level of a transtibial amputation. A transfemoral level amputation is not a preferred level from 211 a functional point of view due to the loss of the knee joint and the increased metabolic cost of 212

ambulation. It is considered when more distal levels are not an option due to inadequate tissue 213 or poor perfusion. An initial transfemoral level amputation (without prior vascular 214

intervention) is performed in rare cases (non-ambulatory patients). The indication for this will 215 be determined by: 216

217

the risk of surgery due to medical comorbidities 218

surgical options 219

the patient’s function and possible rehabilitation 220

the patient’s cognitive status and ability to show carryover in therapies 221 222 Guideline #1.5: When determining the level of amputation, preoperative mobility and the 223 prospects for postoperative mobility should be taken into account. 224 225 Updated Evidence: Predicting whether a patient will use a prosthesis is a clinical 226

judgement taking many factors (physical, medical, psychological, and social) into account. 227 It is important to weigh the chances of successful vascular reconstruction - and subsequent 228 mobility – against the chance of healing and mobility following initial amputation. 229

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230 Functional outcomes after amputation are highly variable and are often related to age, 231

premorbid function and medical comorbidities. At 1 year post-amputation, functional 232 prosthetic use is reported in 47%-70% of persons with limb loss.14, 23-27 Persons with 233 transtibial level amputation were more likely to be prosthetic ambulators (60-70%) than 234 those with transfemoral level amputation (40-50%).25, 26 In one study, 5 years post-235 amputation, the number of prosthetic ambulators decreased to 17%.23 236

237 Increased age is associated with poor functional outcomes after amputation.25, 27, 28 238 Schoppen reported a very low functional level in amputees over 60 years old.27 Those over 239 75 years old rarely used a prosthesis or were ambulatory.14 240 241

The perioperative consultation should address the likelihood of successful prosthetic fitting and 242

use. This can assist the team to determine the optimal level of amputation. If a patient is 243 not a prosthetic candidate, they may be better served with a transfemoral level amputation. 244

245 Premorbid level of function is also predictive of post-amputation level of function.29 246 Patients who are non-ambulatory prior to amputation are unlikely to resume ambulation 247

after amputation.14 248 249 Post-amputation function is also influenced by the patient’s medical and social condition. 250

Increased medical comorbidities are associated with poorer function.29 In particular, 251 chronic obstructive pulmonary disease, end-stage renal disease requiring hemodialysis, 252

diabetes, hypertension, alcohol use disorder and history of treatment for anxiety or 253 depression are all associated with worse functional outcomes.25, 28 On the contrary, white 254 race, being married and having at least a high school education are associated with better 255

outcomes.25 256

257 Outcomes in the rehabilitation phase are difficult to generalize due to the different outcome 258 measures used. Patients successfully receive prostheses in 68% of cases.30 The main factors 259

associated with mobility are age, length of stay in a rehabilitation facility, and the mobility level 260

prior to surgery.27, 30 Wound complications,30 a higher amputation level,26, 31 older age26, 27, 30, 31 261 and a low level of mobility before surgery often result in unsuccessful prosthetic fitting.26, 27 262 Factors associated with functional status include age,27, presence of diabetes mellitus,32 standing 263 balance and cognition.27 264 265

A subset of patients experienced improvements in their functional mobility after 266 amputation. Norvell reported that 37% of individuals with amputation returned to or 267 exceeded their premorbid level of function at 1 year post-amputation.28 Johnson also 268

reported that many persons with unilateral transtibial amputation are able to maintain or 269 improve their function after amputation.29 Because patients undergoing lower extremity 270 amputation due to vascular disease have often been functionally limited by peripheral 271 arterial disease, foot ulcers, infections, and weight-bearing restrictions (sometimes for 272

years prior to amputation) definitive management with amputation surgery can sometimes 273 improve their function. 274 275 Patients who were only moderately mobile prior to amputation will be less likely to become 276 successfully mobile after amputation. In patients with limited mobility, dementia, end-stage 277

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renal disease and/or severe coronary artery disease; a knee disarticulation or transfemoral 278 amputation should be considered.26 279

280 With a flexion contracture of the knee, a knee disarticulation or long transfemoral amputation 281 may provide a superior option. Conversely, a knee disarticulation is an option worth exploring 282 when a transfemoral amputation is being considered. 283 284

It has been suggested that persons with amputations comprise 2 distinct groups: the fit 285 (often traumatic amputation); and the older, medically unfit patient who has vascular 286 disease and a poor prognosis.33 Among this latter group, there is a great variation in 287 functional outcome dependent on age, medical status and other factors. The ability to 288 predict which among these patients are prosthetic candidates may reduce the costs and 289

burden of care resulting from unsuccessful prosthetic fitting and allow earlier focus on 290

interventions that will increase the patient’s independence and quality of life. 291 292

Interestingly, when prosthetic fitting patterns were examined over 40 years, no marked 293 changes in the rate of fitting or wear patterns occurred, despite technologic developments, 294 advances in revascularization procedures, and provision of rehabilitation services. This 295

suggests that a physiologic limit to successful prosthetic fitting may exist in the geriatric 296 patient due to advanced age and comorbidity. This will have implications on health care 297 allocation in the future, as the number of major lower-extremity amputations due to 298

dysvascular disease increases.34 299 300

SURGICAL TECHNIQUE IN LOWER EXTREMITY AMPUTATION DUE TO 301 VASCULAR DISEASE 302

303 Guidelines #2.1: Good surgical technique, which ensures no excess soft tissue, no neuromas, 304

a good residual limb shape, mobile scars and no joint contracture, helps to ensure that the 305 patient has a 10-20% greater chance of postoperative mobility. An experienced surgeon 306 achieves better results, both in terms of possible mobility and lower risk of re-amputation.35 307

308

Updated Evidence: Amputation surgery should be viewed as a reconstructive procedure. The 309 working group recommends that amputations be carried out by experienced, prosthetically 310 aware, surgeons who conduct a minimum of 5 to 10 amputations each year. The absolute 311 number per year is less important than involvement with a multidisciplinary team with good 312 outcomes. 313

314 The basic principle of all amputations is preservation of maximal length consistent with optimal 315 function, control of disease, and satisfactory surgical wound management. Adherent scarred 316

distal tissues or redundant soft tissue should be avoided. 317 318 At all levels of lower extremity and hindquarter amputations, nerves are encountered which 319 require transection. For larger nerves such at the sciatic and femoral nerves, the nerves 320

should be suture ligated prior to transection since they are accompanied by a large vasa 321 nervorum. All nerves should be transected sharply under tension. Prior to allowing the 322 nerve to retract, they can be infiltrated with local anesthetic to provide postoperative pain 323 control. The transected nerve is then allowed to retract into the adjacent soft tissues, away 324 from the areas where it could become adherent or a source of pressure irritation from the 325

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socket. 326 327

An attempt should be made to minimize possible complications following lower extremity 328 amputation. The working group believes that patients facing amputation require subsequent 329 supervision and treatment by a multidisciplinary team in the hospital, with continuation of 330 outpatient rehabilitation treatment in a rehabilitation center, nursing home or at home. (Expert 331 opinion of working group) 332

333 Guidelines #2.2: A comparison of ‘two-stage transtibial amputation (guillotine amputation at 334 the ankle followed by a long posterior flap transtibial amputation with delayed initial skin 335 closure) with ‘one-stage transtibial amputation’ in a small RCT of 30 patients showed a better 336 stump healing after six months in the 'two-stage' group (OR 0.08; CI 0.01-0.89). However, there 337

was no difference in the postoperative infection rate or the re-amputation rate.36 Mobility did not 338

differ significantly (47% in the 'two-stage' group and 54% in the 'one-stage' group). 339

Updated Evidence: There are indications that 'two-stage' transtibial amputation stump results in 340 better healing than the 'one-stage' technique with 'long posterior flap', but it does not lead to 341

improved long term outcomes20 342 343 Intraoperatively meticulous handling of the skin and soft-tissues is critical as traumatic 344 handling can lead to postoperative wound necrosis and further complications. Skin incisions 345

should be made in a layered fashion first only going through skin, then through the 346 subcutaneous tissues, fascia and deeper layers. This allows for a layered closure and 347 obtaining full thickness soft-tissue flaps. An incision straight through skin, subcutaneous 348

tissue and fascia is not advised as this makes it difficult to obtain a robust layered closure. 349 The wound is typically closed from the periphery moving central in order to avoid “dog-350

ears”. If “dog-ears” are present, they should not be trimmed as this could lead to flap 351

failure. The wound should be closed without tension. 352

353 Guideline #2.3: In a trial by the Joint Vascular Research Group (n=191), 'skew flap' transtibial 354

amputation was compared with 'long posterior flap' transtibial amputation.37 After almost 12 355 months, no difference in stump healing, infection or re-amputation rate was found. Mobility 356 (60% for 'skew flaps' and 49% for 'long posterior flap') was also not significantly different (RR 357

1.22; 95% confidence interval (CI) 0.94-1.58). 358 359

Updated Evidence: There is no evidence that the ‘skew flap’ procedure gives better results 360 than ‘long posterior flap’ procedure.20 A well-fashioned ‘skew flap’ will facilitate mobilization 361 with less initial volume reduction. 362

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A small RCT with 41 patients showed that residual limb healing in patients treated with a 364 'sagittal flap' (58%) did not differ from that of patients treated with a 'long posterior flap' (55%) 365 (OR 1:04; CI 0:45 to 2:43). There was no difference in the re-amputation rate, the percentage 366

with a suitable prosthesis or mortality between the two groups. Mobility was also equivalent.38 367 368

The outcome of a standard surgical (sagittal incision) procedure in 217 consecutive patients that 369 underwent initial unilateral transtibial amputation due to peripheral arterial disease was 370 followed for 10 years.39 119 (55%) were fit with a definitive prosthesis at a median time of 41 371

(range, 12–147) days after amputation. 372

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373 Evidence suggests that a transtibial amputation with a ‘sagittal flap’ does not give superior 374

results compared with a ‘long posterior flap’.20 375 376 Guideline #2.4: A rule of thumb is that an osseous length of 10-15 cm below the medial knee 377 joint gap is optimal in a transtibial amputation. 378 379

Updated Evidence: In a transtibial amputation, an osseous length of 10-15 cm below the medial 380 knee joint has been thought to be optimal. Alternatively, the length of the amputated tibia can be 381 equal to the width of the tibial plateau. There is literature that supports that longer residual limbs 382 result in reduced metabolic energy expenditure. A longer residual limb up to 19 centimeters, as 383 long as it is compatible with soft tissue coverage and healing, may be optimal. The fibula is 384

typically cut 1.5 cm proximal to the planned tibial cut and then a further 2-3 cm more 385

proximal, to assist with exposure of the deeper posterior compartment and assist with wound 386 closure. The distal bones are cut at an angle of 40-60 degrees and filed to prevent damage to the 387

myocutaneous flap. If the bone is cut with the aid of a mechanically driven saw, cooling with 388 physiological saline can prevent thermal injury to the bone (an ischemic leg has no heat 389 regulatory mechanisms). Irrigating the wound also prevents contamination with bone meal. 390

391 Guideline #2.5: Evidence for surgical techniques in transfemoral amputations and knee 392 disarticulation is limited. 393

394 Updated Evidence: Flap design for a knee disarticulation amputation is different from other 395

distal leg amputations since the main flap relies on the anterior skin and soft tissue. A fish 396 mouth incision with a flap that is twice as long anteriorly as it is posteriorly is used. This is 397

to allow adequate mobilization of the patella tendon. 398

For individuals with vascular disease, knee disarticulation is a relatively rare level of 399

amputation compared to transtibial and transfemoral levels. The benefits of this level 400 include no disruption of the bony cortex, greater proprioception, greater end weight-bearing 401

ability and the long lever arm of the residual limb. The drawbacks are poor cosmesis due to 402 the bulbous shape of the distal limb and less room for knee components. The leg lengths of 403 the prosthetic and sound thigh can appear uneven at this level, especially in sitting. With 404

amputation due to vascular disease, a transfemoral amputation is more common than a 405 knee disarticulation. 406

407 In a transfemoral amputation the goal is to maintain the maximum length possible. The ideal 408 length of a transfemoral residual limb is 5-7 cm proximal to the knee joint. The 409

contralateral side should be taken as a benchmark. Flap design is based on the medial and 410

lateral soft-tissues. Similar to other amputations, a fish-mouth designed flap is used, with a 411 medial flap that is longer than the lateral flap. This is to allow mobilization of the adductor 412 muscle group and perform a myodesis. The femur is typically transected 12 cm proximal to 413

the knee joint. This allows the adductor magnus to be used as a dynamic stabilizer of the 414 residual limb. The hip adductor muscles, in particular the adductor magnus are important 415 in countering lateral movements of the femur. As the amputation is taken more proximal, 416 there is a reduction in the strength of the adductor and less stabilization. If the residual 417 limb is too short, an abduction contracture may occur. It is also important to avoid a 418

flexion contracture of the hip. (Expert opinion of working group) 419

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420 Guideline #2.6: Choksy, et al., found the use of a tourniquet resulted in less blood loss and 421

lower transfusion requirements.40 In an observational, feasibility study of 89 patients who 422 underwent a transtibial amputation, Wolthuis, et al. found similar reductions in blood loss and 423 transfusion requirements and a significant reduction in the number of stump revisions.41 424 425 Updated Evidence: The use of a tourniquet in transtibial amputation is recommended because 426

tourniquet use results in less blood loss and may also result in fewer stump revisions. (Expert 427

opinion of working group) 428

Skin incisions should be made under tourniquet control. Meticulous hemostasis is 429 mandatory to avoid postoperative hematoma. It is essential that all larger blood vessels are 430 suture ligated, and when indicated oversewn. All wounds are drained for at least 48 hours 431 postoperatively. It is not uncommon to have drains in place longer for more proximal level 432

amputations. Incisional negative pressure wound dressings can also be used for hip 433

disarticulations and hindquarter amputations to reduce wound drainage. 434

Guideline #2.7: There are some reports regarding bone bridging in transtibial amputation (Ertl 435 procedure). 436

437 Updated Evidence: Because of the longer surgical and tourniquet times associated with the bone 438

bridge synostosis technique,42 it is best reserved for young, healthy individuals. 439 440

Guideline #2.8: Complications can be divided into disorders that lead to delayed wound 441

healing (wound edge necrosis, dehiscence and infection) and those that are more severe 442 (progressive ischemia with extensive necrosis, infection, revision, venous thromboembolism, 443

sepsis and death). 444

445

Wound healing is of primary importance after amputation due to the morbidity associated 446 with delayed wound healing and re-amputation. Wound care, edema management, diabetic 447

control, smoking cessation and adequate nutrition are all important factors. Optimally, 448 wound healing takes 6-8 weeks after amputation. Amputations due to vascular disease may 449

have a more prolonged course. Healing for a transmetatarsal amputation due to vascular 450 disease ranged from 3-20 months with a mean of 7 months.43 Healing at 100 and 200 days 451

was 55% and 83% for transtibial and 76% and 85% for transfemoral amputations.14 452

A systematic review by McIntosh44 looking at the effect of prophylactic antibiotics on infection 453 following amputation suggested the use of prophylactic antibiotics resulted in significantly fewer 454 residual limb infections in comparison with placebo or no antibiotics. The working group 455

recommends perioperative antibiotic treatment in the form a perioperative bolus or five days 456

starting immediately postoperatively. 457

Robertson45 reviewed the literature regarding the effectiveness of thromboprophylaxis in 458 preventing venous thromboembolism in people undergoing major lower extremity amputation. 459 Only two studies were included in this review, each comparing different interventions. There is 460

inadequate evidence to make any conclusions regarding the most effective thromboprophylaxis 461 regimen in patients undergoing lower limb amputation. 462 463

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Mortality after amputation is very high in the dysvascular population. 30 day mortality after 464 amputation is 8-10%.14, 46, 47 1 year survival is 60-70% and 5 year survival is 35% following 465

amputation due to vascular disease.46, 48 466

A cohort study by Stone49 retrospectively evaluated 380 patients (median age 67 years) 467

following recovery from transtibial or transfemoral amputation. The exclusion criterion was 468 amputation due to trauma. The results showed a perioperative mortality of 15.5% (n=59) in this 469 population, with a prevalence of wound complications after 90 days of 13.4% (n=51). 470 Reamputation was performed significantly more often in patients who had undergone a 471 transtibial amputation, while patients with a transfemoral amputation often underwent a local 472

revision (p =0.0006). The same result was seen in a study by Cruz;50 in 229 patients (average 473 age 68.8 years) who required amputation (transtibial (n=119), transfemoral (n=177)), a 474 significant difference in revision of the original amputation was seen in the group with a 475

transtibial amputation (P> 0.0001). 476

Morse51 (n=50) and Kock52 (n=66) both studied retrospective cohorts of patients who had 477 undergone knee disarticulation due to PAD. The patients in the study by Morse51 had a modified 478 Mazet technique, while patients in the study by Kock52 had a dorsal gastrocnemius muscle flap 479 to close the wound. The results were comparable. In the Morse cohort 3 patients died (6%) as a 480

result of surgery, 9 patients (19%) required revision to a transfemoral amputation due to delayed 481 healing and 41 patients (81%) showed good wound healing. In the cohort studied by Kock52 6 482

patients died perioperatively (9%), 9 patients (13%) required revision amputation surgery up to 483 the hip, and 6 patients (9%) needed an additional operation on soft tissue. Wound healing was 484 successful in 48 patients (80%). 485

486 Nehler14 studied a cohort of 154 patients (median age 62 years) who had one or more 487

amputation(s) (transfemoral amputation (n=78), transtibial amputation (n=94)). Reasons for 488

exclusion were non-ambulatory, dementia, or neurologic disorders. The results showed a 489

perioperative mortality of 10%. 57 revision surgeries were required (transtibial amputation 490 (n=23); transfemoral amputation (n=16); transfemoral reamputation in 18 patients (19%)). 491

492 Campbell53 retrospectively studied a cohort of 312 patients with one or more lower extremity 493

amputation(s) (transtibial, n=192; transfemoral, n=122; Gritti-Stokes, n=34; hip disarticulation, 494 n=1). The study looked at the overall revision rate (12%) and perioperative mortality within 30 495 days (18%). Although no statistical analysis comparing the different levels of amputation was 496

reported, individual percentages showed that the transtibial group had the highest revision 497 percentage (19%), and perioperative mortality was highest in the groups that required 498

transfemoral or Gritti-Stokes amputation (both 24%). 499 500

Johannesson54 prospectively followed 190 patients undergoing lower extremity amputation over 501

a period of 4 years. The results showed that 27 patients died within one month of surgery, 24 502 patients required reamputation (16 transfemoral, 8 transtibial), and 5 patients with transfemoral 503 amputation, required reamputation twice. 504 505

Certain comorbid conditions increase risk. Perioperative sepsis, congestive heart failure, 506 renal failure and liver disease were associated with higher mortality in hospital, at 30 days 507 and at 1 year.46, 55 1 year and 5 year survival was found to be comparable in patients with 508 diabetes (69.4% and 30.9% survival at 1 and 5 years), but much worse in patients with either 509 end-stage renal disease (51.9% and 14.4% survival at 1 and 5 years) or renal insufficiency 510

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(55.9% and 19.4% at 1 and 5 years).46 Patients with renal insufficiency were also more 511

likely to undergo repeat amputation within 30 days.56 512

Higher level of amputation is also associated with increased mortality. Mortality from in 513 hospital to 5 years is higher for those with transfemoral compared to transtibial 514

amputation.46, 55 1 year survival was 75% in persons with transtibial compared to 50% with 515 transfemoral amputation. 5 year survival was 38% with transtibial level amputation 516

compared to 23% with transfemoral amputation.46 517

Given the high mortality after amputation due to vascular disease, it is important to identify 518 appropriate interventions and rehabilitation goals to improve mobility, independence and 519 quality of life early following amputation. Delayed wound healing will mean more time 520

spent in the hospital, more medical appointments, and greater burden of care over many 521 months. It is important to discuss prognosis and realistic goals with the patient and their 522

family to avoid a prolonged period trying to heal a distal amputation or attempting 523

prosthetic rehabilitation, if they are unlikely to be a functional prosthetic user. Some may be 524

better served by a more proximal amputation, successful healing, and wheelchair mobility. 525

Postoperative Management in the Immediate Postoperative Period (Up to Three Days) 526 and Early Rehabilitation 527 528 Guideline #3.1: The benefits of soft dressings are ease of application, low cost and easy 529 access to the wound. The drawbacks include: they become loose and fall off; they do not 530 prevent joint contracture; they cause risk of a “choke” of the distal residual limb if too 531

much compression is applied proximally and they do not protect the limb in the event of a 532 fall. 533

534

Updated Evidence: The advantages of the classic elastic stump dressing as described in the 535

literature (bandage method) are based on the simplicity of the method, the minimal time 536 required, the use of widely available materials and possibility for frequent wound inspection.57, 537 58 538 539 Different kinds of soft or compressive dressings include self-adherent compressive 540 bandage, figure of 8 compressive wrap, and a postoperative prosthetic sock with a garter 541

belt suspension. 542 543 Known disadvantages are the experience required (in application of the dressing) by the persons 544 applying the dressing, the high local or proximally generated pressures that may negatively 545 affect healing, the required frequency (4 to 6 times daily) of application, the tendency of the 546

dressings to loosen and sag and the limited protection of the amputation stump.57, 58 A number 547

of these disadvantages can be overcome by the use of elastic compression socks (stump 548

shrinkers), or silicone liners when tolerated. No comparative studies were found on this 549 subject. The treatment team’s experience with a particular method is of obvious importance.58 550 551 Guideline #3.2: Rigid dressings can be applied to the residual limb in the postoperative period 552 to help optimize wound healing, control edema, shape the residual limb, prevent contracture, 553

protect the limb and control pain. 554 555

Updated Evidence: There are different types of dressings that can be applied to the 556

13

residual limb in the postoperative period to help protect the limb and control edema. For 557 transtibial amputations, either a rigid or a soft dressing can be used. Following 558

transfemoral amputation, typically soft dressings are used. 559 560 The effect of a rigid stump dressing was first described by Pieter Verduyn Adriaansz in 1696: 561 "Nouvelle method amputer pour les membres."58 This technique would later be applied during 562 the First World War and improved versions were described in the 1960s and 1970s by 563

Berlemont (1961),59, 60 Weiss (1966),61, 62 and Burgess (1978).63 The principle is that of a plaster 564 bandage that is applied to the stump immediately postoperatively (direct or immediate fitting) or 565 after a few days (delayed postoperative fitting), and remains in place for between 5 days and 3 566 weeks. 567 568

There is a considerable body of evidence in the literature in favor of rigid dressings applied 569

directly after the amputation.64 Advantages of rigid dressings include edema management 570 prevention of contracture, and protection in case of a fall. The use of a rigid removable dressing 571

is thought to facilitate early mobilization. A randomized controlled study by Traballesi65 572 showed that the use of a vacuum-assisted socket system allowed early fitting. The benefits of a 573 non-removable rigid dressing are that they help to control edema, protect the limb from 574

trauma, prevent knee flexion contracture, reduce pain, and increase tolerance to weight-575 bearing. The drawbacks of a non-removable plaster cast are that it requires weekly 576 application by a skilled professional, prevents monitoring of the wound and is heavier and 577

more costly than a soft dressing. 578 579

A nonremovable rigid dressing allows the attachment of an immediate (or early) 580 postoperative prosthesis, which includes a connector, pylon and foot. The pylon cast has 581 been purported to allow patients with transtibial amputations the opportunity for early 582

ambulation without increased complications compared with other postoperative 583

dressings.66, 67 At the transfemoral level, a locking knee is used in the early postoperative 584 provisional prosthesis to avoid excess motion and shearing along the surgical incision. 585 586

The impact of early weight-bearing on wound healing is unclear. Potential complications 587

include tissue necrosis if incorrectly applied and mechanical tissue trauma inside the cast.57 588 Despite a pylon cast, patients were mostly sedentary and had a low quality of life in the first 589 six weeks after transtibial amputation.68 590 591 A rigid removable dressing can be taken off to monitor the incision and is less heavy and 592

costly than a non-removable rigid dressing. Studies of rigid dressings show that they 593 decrease time to prosthetic fitting compared to other management.64, 69-71 The comparison 594 between a rigid removable dressing (RRD) and an elastic bandage on the reduction of stump 595

volume was investigated by Janchai.72 A clear but non-significant trend (p =0.064) was 596 observed in favour of the RRD, but only in the first 2 weeks of use. This difference disappeared 597 completely in the following two weeks. These findings are also supported by the systematic 598 review by Nawijn,73 which further notes that most studies were particularly weak in terms of 599

patient numbers. 600 601

Before initiating any type of dressing, the team should be well prepared and trained. Before 602

switching to using rigid dressings for postoperative management, all logistical obstacles should 603

be overcome. If there is a lack of experience, choose the easiest method with least risk of 604

14

complication. With transfemoral level amputation, rigid stump dressings can be challenging 605

(incontinence, suspension). Postoperative management with light elastic bandages or stump 606 socks may be preferable. 607

608 Although it is generally assumed (and reported in some descriptive and case studies) that rigid 609 dressings achieve better pain reduction than elastic bandages, no significant evidence for this 610

was found in the selected controlled trials. This may be due to the lack of power in these studies 611 or the lack of suitably sensitive instruments to quantify postoperative pain.57 Thus far, this 612 pain-reducing effect has not been demonstrated. 613 614 The working group recommends a rigid dressing as the treatment of choice during the early 615

postoperative phase for persons with transtibial or knee disarticulation level amputations. 616 617

After using a rigid dressing, compression is used to shape the limb prior to prosthetic fitting. 618 Different methods are used around the world (elastic bandage, socks within RRD, compression 619 garments or liners) with very little or no scientific evidence. 620

621 Guideline #3.3: Patients should be educated about stretching and positioning to avoid joint 622

contracture. 623

624 Updated Evidence: Education is provided to optimize positioning; to avoid contracture or 625 dependent edema; review mobility, balance training, and safety. Maintaining knee mobility is 626

of great importance in the postoperative phase. There is a tendency to keep the knee bent, 627 particularly in the presence of postoperative pain. A rigid nonremovable dressing (extending 628

above the knee) can prevent knee flexion contracture. (Expert opinion of working group) 629 630

To prevent hip flexion contracture, patients are educated to spend time prone with a pillow 631 or towel under the anterior thigh (if tolerated). Knee flexion contractures can be prevented 632

by using an elevated leg rest on the wheelchair, a residual limb support, and by educating 633 the patient in proper positioning (avoid lying supine with a pillow under the knee). 634 Although the focus is usually on the amputated side, attention should also be paid to the 635

contralateral side. It is important to ensure that the contralateral leg (heel) is well-protected 636 against pressure ulcers, both in the preoperative phase, during surgery and in the postoperative 637 immobilization phase. 638

639

The Rehabilitation Process from Amputation to Initial Prosthetic Management 640 641 Guidelines#4.1: Treatment should be consistent, consistently implemented, and follow a set 642 framework or care plan. Information is a vital part of any medical treatment. Any information 643

must be tailored to the specific needs of the individual and included in their medical record. 644 645

Updated Evidence: The main objective in the period from amputation to initial prosthetic 646 fitting is to focus on recovery from the surgery, achieve medical stability, prevent complications 647

and optimize mobility. This includes pain management, surgical site management, residual limb 648 management (edema control, strengthening, and range of motion), psychological support, 649 therapy, and care of the contralateral limb.58 650 651

Objectives should be suited to the future needs of the patient. Discussions should take place not 652

15

only in the presence of the patient, but also with the involvement of family members and other 653 caregivers. 654

655 Information for patients (electronic, oral, or written) and those directly involved in the patient’s 656 care is an essential component in the treatment of patients undergoing lower extremity 657 amputation. As treatment involves multiple disciplines, it is advisable that items discussed are 658 recorded in a manner that is clear to all disciplines. Information resources should be developed 659

at the local level. (Expert opinion of working group) 660 661 The relationship between shared decision-making and evidence-based practice is becoming 662 increasingly recognized.74 Shared decision-making provides a process for bringing evidence 663 into the consultation and incorporating it into discussions with the patient, along with 664

discussions about the patient’s values and preferences. Shared decision-making may also help 665

reduce the unwarranted variation in care.75 666 667

To optimize the rehabilitation process, the team will determine the patients’ perioperative 668 function, sock management, the importance of monitoring their skin, the impact of weight 669 change on prosthetic fit, nutritional status (ideally a dietician will help optimize nutrition status), 670

strength, range of motion (quality of the musculoskeletal system), daily living activities, 671 adjustment to their impairment, and social situation. 672 673

Verbal education and printed materials are provided by various members of the rehabilitation 674 team throughout the hospital stay. Education includes adjusting/adaptation to limb loss, 675

optimizing functional mobility (bed mobility, wheelchair mobility, ambulation, and transfers), 676 optimizing daily living skills, obtaining appropriate adaptive and durable medical equipment, 677 caregiver support, communication with other care providers, decision-making on health risks, 678

optimizing care options (including prosthetic fitting, prosthetic adjustments, prosthetic training, 679

cardiovascular conditioning, risk factor prevention, and accessing emergency care if necessary). 680 681 The person with limb loss and their family are instructed in measures to avoid further limb loss, 682

risk factors with the use of a prosthesis, fall prevention and management, home modifications, 683

home safety, energy conservation, and expenditure. Also addressed is the importance of follow 684 up to prevent complications, information about consumer groups, and peer support including 685 how to access them. Assistance in locating and accessing appropriate resources in local 686 communities for self-advocacy, financial assistance, emotional support, and support groups are 687 provided with phone numbers and numbers of contact persons, and documented in the medical 688

record. 689 690 In the perioperative period, the team works with social services to develop and implement the 691

discharge plan including follow-up clinical care services and interventions that address the use 692 of financial resources, equipment, and community support as indicated by individual patient’s 693 needs. 694 695

Verbal information should be supported in other formats, as patients and their relatives (and 696 other parties involved) often do not hear and/or remember everything. The format (oral, digital, 697 leaflets) in which the information is provided will need to be tailored to the patient. 698

699 When the treatment plan has changed in the course of the treatment for any reason, this must be 700

16

explained and discussed with the patient. In the case of transfer to another healthcare institution, 701 a satisfactory transfer of information must take place. 702

703 The discharge summary includes an acute medical history, rehabilitation medical history, 704 description of the rehabilitation course, and ongoing care needs. The discharge summary also 705 outlines the plan for community-based services (pedorthotic services, foot care, health or 706 behavioral issues that require follow up). The discharge summary is reviewed by the patient 707

and their family/support system. In addition, a copy of the discharge summary is sent to the 708 primary physician as designated by the patient or the healthcare facility to which the patient 709 transitions. The discharge plan is updated throughout the course of the patient’s stay and is 710 reassessed frequently to ensure that the patient’s continuing care needs are identified. The 711 following factors are assessed: the patient’s ability to return to their previous level of 712

functioning; identification of resources previously used or those necessary to facilitate 713

continuity of care; social/family support; medical needs. The discharge plan is documented in 714 the medical record including patient assessment data and a plan for continuing care. 715

716 It is useful to prepare a checklist detailing the minimum information that should be provided to 717 the patient. This can be completed and supplemented by every practitioner involved in the 718

treatment. Developing a single information dossier should be considered so that each discipline 719 can see which items have already been discussed and what may still need attention. 720

721

Guideline #4.2: Intensive therapy following lower extremity amputation improves function. 722 723

Updated Evidence: An intensive physical therapy program for patients with a lower extremity 724 amputation results in better load-bearing capacity and an improved 2-minute walk test, in 725 comparison with a less intensive treatment program.76 Patients who receive inpatient 726

rehabilitation after lower extremity amputation have a better 1-year survival rate, greater success 727

with prosthesis fitting, and are more likely to return home than patients not receiving inpatient 728 rehabilitation.48, 77, 78 There is evidence that patients in a clinical rehabilitation program are 729 more likely to return home than patients who receive routine care.79 730

731

An analysis of changes over time showed that in the course of a 12-year study, the use of 732 inpatient rehabilitation showed substantial growth (skilled nursing facilities, 31% in 1986 to 733 55% in 1997; rehabilitation facilities, 2% in 1986 to 13% in 1997). Other research shows 734 roughly the same numbers regarding discharge to rehabilitation facilities (16%) and skilled 735 nursing facilities (32%).80 Patients who were discharged to a skilled nursing facility were often 736

older than 75 years, female, and had a higher level of amputation. The comorbidity score was 737 not significantly different between patients discharged to a rehabilitation facility compared with 738 patients discharged to a skilled nursing facility for further rehabilitation. Patients referred to 739

rehabilitation facilities were more likely to have diabetes.48 Research from the Netherlands 740 shows that 86% of patients referred to a rehabilitation facility returned home after completion 741 of the rehabilitation program. (Dutch Guideline 2012). 742 743

In a multicentre study of rehabilitation after amputation of a lower limb in nursing homes in the 744 Netherlands, 65% of the patients were discharged to independent living, and 50% of patients 745 were successfully fit with a prosthesis. Determinants for successful fitting of a prosthesis were 746 good walking ability at admission to the nursing home, absence of phantom pain and transtibial 747 (as opposed to transfemoral) level amputation.81 748

17

749 Following lower limb amputation, discharge planning should be based on the degree of 750

function, social situation, and the patient’s health. 751 752 In a retrospective study of the Medicare claims database in the U.S., the discharge destination 753 that yielded the best results after amputation was examined for 2468 elderly patients who 754 underwent an lower extremity amputation. The 1-year survival was highest in patients 755

discharged to a rehabilitation centre (75%), followed by a nursing home (“skilled nursing 756 facility”) (63%) and to home (51%). The percentages for successful prosthetic prescriptions 757 were 73%, 58% and 49%, respectively. Although nursing home patients were older, they did 758 not show greater comorbidity.48 A retrospective study by the U.S. Veterans Administration 759 compared specialized rehabilitation with rehabilitation on general surgical wards for 1339 760

veterans. After adjustment for prognostic differences, 1-year survival (91% vs. 76%), the 761

percentage with a home discharge (84% vs. 73%) and the percentage fitted with a prosthesis 762 (40% vs. 19%) was better in a specialised rehabilitation setting (p <0.0001 for all 763

comparisons).77 Another retrospective study from the U.S. involved 2673 patients from the 764 Veterans Administration who underwent transfemoral amputation. After adjustment for 765 prognostic differences, the 1-year survival of those in acute inpatient rehabilitation (in an 766

integrated care system) (OR 1.9, CI 1.7-2.3) was again higher. More patients went home (OR 767 3.4; CI 2.9-4.0) and more patients received a prosthesis (OR 1.5, CI 1.2-1.8) than did those who 768 received no rehabilitation.78 An additional study showed that persons with amputation who 769

received specialized rehabilitation had motor FIM gains that were on average 8.0 points greater 770 than those who received consultative rehabilitation. It was suggested that those receiving 771

specialized rehabilitation can be expected to make comparatively greater gains, regardless of 772 timing and clinical complexity82 A certain degree of bias is present in these studies because 773 groups of patients were selected on the basis of their degree of functioning. 774

775

In a Dutch study, the effect of the ‘Rehabilitation Activity Profile’(RAP) on outcome was 776 studied in various rehabilitation patients, including amputation patients. Following the 777 introduction of RAP into four teams over a period of 2 years, the Barthel index was actually 778

slightly lower compared with patients treated by teams without RAP. The authors suspected that 779

it was too early to see possible improvements.83 780 781 In a small observational study of 60 patients who underwent a transtibial amputation, the effect 782 of inpatient rehabilitation was compared with outpatient (home-based) rehabilitation. After 12-783 29 weeks, no difference was observed in the use of the prosthesis. Patients in the group with 784

outpatient rehabilitation were more satisfied and experienced more social support than patients 785 in inpatient rehabilitation.84 In a retrospective study of 146 patients with trauma-related 786 amputations, the effect of rehabilitation was compared with other forms of care. After 787

multivariate analysis, patients with inpatient rehabilitation were found to be in better health.85 788 789

Specific attention should be paid to hip strengthening training. In a twice weekly hip 790 strengthening program, the training group increased hip strength and decreased oxygen 791

consumption compared to a control group, who continued their usual activities. Hip strength 792 was reduced in the group not following the training program.86 Another study showed 793 improvement of functional performance and balance confidence following intense hip abductor 794 strength training during an 8-week program of twice weekly hip abductor strength training or 795 arm ergometry.87 796

18

797 Guideline #4.3: While in the hospital, the multidisciplinary rehabilitation team determines the 798

discharge destination for a patient with lower limb amputation based on the expected degree of 799 functioning, social situation, and medical comorbidities. 800

801 Updated Evidence: Another important perioperative goal is to ensure that the patient can 802 adequately function in their home with or without a prosthesis on discharge. This should 803

include evaluation for adaptive and durable medical equipment needs. If the patient cannot 804 safely function in their home environment after amputation, discharge to a rehabilitation 805

setting is necessary. 806

In addition to the patient’s functional ability, the home setup, caregivers, and support network 807 are of great importance. The rehabilitation consultant will attempt to optimize the patient’s 808 achievable level of function. This depends on both the amputation level and premorbid 809

function.26 810 811 A final discharge destination is determined, usually in a multidisciplinary consultation. A large 812

population-based study in the U.S.88 showed that 41% of patients with vascular disease 813 requiring amputation are discharged to their homes, 37% to a skilled nursing facility, and 10% 814 to a rehabilitation facility. 815

816

Guideline #4.4: Following amputation, a patient needs to adapt to an altered body, 817 postoperative management (possibly a prosthesis), and an altered future. 818

819

Updated Evidence: The most frequently described psychological adjustment issues are mood 820 disorders and anxiety. In the course of rehabilitation, the adaptation process and the 821

psychological aspects that are associated with it need to be considered. The working group 822

recommends a psychologist and/or social worker be part of the rehabilitation team for both the 823

diagnosis and treatment of patients undergoing amputation. 824 825

Concern may arise due to altered self-esteem and body image. The impact on quality of life has 826 been described in several studies, including treatment of mental health problems, lack of social 827 support, adjusting to a new situation, and change of body image. These studies describe the 828

influence of coping on the process of adjustment and, in a few cases, the role the prosthesis 829 plays in the process. Social support positively influences the adjustment process.89-93 830

831 The working group believes that optimal learning methods, coping styles, and skills should be 832 determined in the diagnosis phase and reassessed during the course of rehabilitation. 833

834

Cognitive decline reduces the chance of successful rehabilitation.94 Cognitive impairment 835 appears to be more prevalent among persons with lower limb amputations than in the general 836 population and is negatively associated with mobility, prosthetic use, and maintaining of 837

independence following amputation.95 Cognitive screening prior to rehabilitation could assist in 838 determining patients’ suitability for a prosthesis versus wheelchair use and decision making for 839 a specific rehabilitation program.95 840 841 Guideline #4.5: Return to work following lower extremity amputation due to vascular disease 842

843

19

Updated Evidence: Although the majority of patients with an amputation due to vascular 844 disease have reached retirement age, there are patients who are of working age at the time of 845

amputation. The literature on return to work following amputation is based largely on patients 846 with amputations due to trauma and tumor. The working group examined factors that play a 847 role in return to work and formulated recommendations that may aid in promoting return to 848 work. If the rehabilitation team does not promote return to work, in whatever form, from early 849 in the process, it may inhibit the patients return to work. The worksite physician should be 850

involved in the rehabilitation process as possible. 851 852 The literature indicates that a large proportion of individuals who undergo lower extremity 853 amputation return to work. One year after the amputation, 42% of have resumed work.96 and 854 after more than one year 58-79% have returned to work or have stopped working for reasons 855

unrelated to the amputation.96-100 A subset of patients (approximately 30%) required 856

adjustments in their work situation to return to work.101 857 858

Residual limb problems and/or wound healing were the main reasons for a delay in return to 859 work in a Dutch retrospective study of 32 patients. Poor support to adjust work responsibilities 860 by the reintegration agency or employer prevented return to work in 34%.102 861

862 Of working patients, 60-80% resumed work after lower extremity amputation. A higher 863 amputation level results in a poorer prognosis for return to work.100, 103 Comorbidities, 864

amputation due to vascular disease, age greater than 40 at the time of amputation, poor 865

prosthetic fit, and limited education, all negatively affect return to work.98, 103 Phantom pain 866

may negatively impact return to work.104 In physically demanding work, the ability to change 867

jobs or the type of work has a positive effect on successful work reintegration.97, 98 The 868 demands of a patient’s workplace should be taken into account when prescribing a prosthesis. 869

870

Pain Management Following Amputation 871

872 Guideline# 5.1: In addition to physical limitations, pain plays a major role (both stump pain and 873 phantom pain) in determining the quality of life.89, 94, 105-115 (Dutch Guideline 2012). 874

875 Updated Evidence: Careful consideration of several patient factors can improve success in 876 medical therapy for phantom and postoperative pain. The patient’s medical comorbidities 877

should be considered. Limiting factors such as pulmonary, cardiovascular, renal, or hepatic 878 impairment should be identified as these may influence medication choice. 879

880 Patients who undergo an amputation will experience moderate to severe acute postoperative 881 pain. In addition to oral and intravenous medications in the treatment of acute postoperative 882

pain, epidural or perineural pain control may also be used. 883 884

In addition to acute pain following amputation, a considerable number of patients develop 885 chronic pain syndromes. Phantom pain, experienced as painful sensations in the amputated 886

limb, is a neuropathic pain syndrome probably caused by central and peripheral neural 887 mechanisms. There is no evidence for prevention of phantom pain. Pharmacologic treatment, 888 psychologic treatment, positioning, and postoperative dressings are important in the 889 management of pain. 890

891

20

Epidural or perineural administration of bupivacaine, compared with placebo, has no significant 892 effect on the intensity or incidence of stump and phantom pain in the early perioperative period 893

up to six months and long-term (12 months).116, 117 118 The methods used are effective in 894 treating acute postoperative pain.119 The working group believes epidural treatment has a place 895 in the perioperative management of pain. 896 897 Anticonvulsants are often used in the treatment of neuropathic pain. Compared with placebo, 898

gabapentin has no effect on the incidence and intensity of stump and phantom pain in the 899 perioperative period up to 6 months.120, 121 Perioperative administration of gabapentin 900 appeared to have no effect on the incidence of phantom pain and chronic stump pain.120 In a 901 recent Cochrane Review,122 these agents showed no benefit in the relief of phantom limb pain. 902 In a small study by Bone,121 gabapentin may have shown an effect on longstanding phantom 903

pain. Pregabalin’s mechanism of action is similar to gabapentin. No studies were found on the 904

effect of pregabalin on phantom pain and chronic stump pain. 905 906

Amitriptyline and nortriptyline have been shown to be effective against neuropathic pain. Their 907 role in the treatment of phantom pain has been poorly investigated. A study by Wilder-Smith123 908 suggested that, in addition to tramadol, amitriptyline may be effective in patients with phantom 909

pain. 910 911 A randomized double-blinded pilot study Wu124 showed that both Botox and Lidocaine/Depo-912

Medrol injected intramuscularly and subcutaneously at local tender points resulted in 913 immediate improvement of residual limb pain (not phantom limb pain) and pain tolerance, 914

which lasted for 6 months in persons with amputation who failed conventional treatments. 915 916 Ketamine (epidural or intravenous), compared with placebo, has no significant effect on the 917

incidence and intensity of stump and phantom pain in the perioperative period up to 6 months 918

and long-term (12 months).125, 126 Due to neurotoxicity, epidural infusion of ketamine cannot 919 be recommended. 920 921

While pain following amputation can prove difficult to treat, there are a variety of therapeutic 922

options including behavioral therapies, physical modalities, topical and oral medications, and 923 implantable devices. Medication side effects can be a barrier to treatment success. A frank 924 conversation discussing common or serious side effects should be performed prior to starting a 925 new treatment. Many of the treatment side effects can be improved over time due to 926 progressive tolerance. Each medication should be maintained at the lowest effective dose. 927

Topical medications, behavioral strategies, and physical modalities can be particularly 928 beneficial in combination with other treatments due to their negligible side effect profiles. 929 930

Specialized modalities used in chronic pain management fall outside of the scope of this 931 guideline. 932 933 Pain research has shown that cognitive behavioral therapy is effective in the perioperative 934

period. Third generation behavioral therapy (Acceptance and Commitment Therapy (ACT) and 935 Mindfulness) also appear to be prominently seen and indicate that future research into these 936 treatment methods is necessary. 937 938

Prosthetic Prescription Following Lower Extremity Amputation due to Vascular Disease 939

21

940 Guideline #6.1: Ideally, a prescription should be generated with a multidisciplinary team 941

including a physician familiar with rehabilitation requirements, a prosthetist, and a physical 942 therapist. 943

944 Updated Evidence: Clinical experience and component availability play an important role in 945 determining an appropriate prescription and may lead to local variations. A clear evidence-946

based rationale cannot always be given for the components chosen. The working group 947 recommends that prosthetic fitting start as soon as possible after the incision has healed. 948 949 When prescribing an initial prosthesis, a multidisciplinary approach is optimal (although this 950 may not be necessary for subsequent prostheses). New technology is constantly being 951

introduced that promises improved function but often at a higher cost. Research focused on 952

quantifying a cost benefit ratio could be a great aid for prescription practices aimed at cost 953 savings. The large number of available components and technical developments mean that 954

knowledge of the properties and the possibilities for patient performance cannot rest with a 955 single discipline. Cooperation and dialogue between different disciplines (rehabilitation 956

physician, prosthetist and therapist) is of great importance. 957

Prescribing a prosthesis is a process which involves assessment, production, delivery and 958 evaluation of a prosthetic leg. Prescription and fitting processes vary significantly between 959

countries. The way national public health insurances are organized also influence the processes 960

and available choices. 961

When determining patient characteristics for a prosthetic prescription, a hierarchical order is 962 maintained and the terminology used is derived from the ‘International Classification of 963

Functioning, Disability and Health’ (ICF). The priority is to review the function and 964

anatomical characteristics of the patient (amputation level and residual limb characteristics). 965

Function and especially the expected mobility level with a prosthesis, being of particular 966 importance. 967

968 The most fundamental question when developing a prosthetic prescription is the patient’s need 969

and their ability to utilize the prosthesis. The key point is the anticipated level of mobility with 970 a prosthesis is the guiding factor in the choice of prosthetic components. 971

972

Different healthcare systems have developed protocols and processes that attempt to increase 973 transparency and objectivity for prosthetic management. An example of a centralized process is 974

the Dutch Protocol (prescription process for leg prosthetics). Central to this process is the 975 formulation of the anticipated activity based on anatomic characteristics, activity and 976 participation; the various domains within the international classification of functioning, 977

disability, and health (ICF). The protocol aims to provide a guideline for the minimum and to 978 support a clear justification for the prosthetic prescription and component selection with 979 maximum transparency for all parties, including the health insurer and the patient. Some 980 healthcare systems provide clear indications for specific components. Others request 981

documented and outcome-based justification of an individual fitting attempt. Choosing between 982 various prosthetic components should be based on reliable evidence-based information on the 983 characteristics of these components. 984

985

22

If the decision is made to prescribe a prosthesis, details of the prosthetic prescription 986 including socket design, suspension, interface, pylon, knee, and foot components (with input 987

from the prosthetist and the patient) is provided. 988

Prosthetic training should be arranged when the initial prosthesis is prescribed. Options 989

include outpatient physical therapy, subacute rehabilitation, or inpatient rehabilitation. Once 990 the prosthesis is fabricated, the physiatrist will often evaluate the fit and quality of the limb 991 before or during prosthetic training. A well-fitting prosthesis with appropriate components, 992

supervised training, and ongoing follow-up optimizes prosthetic use and function. 993

A patient must understand that successful prosthetic rehabilitation is a prerequisite for 994 optimal performance. A state-of-the-art prosthesis will not provide optimal performance to a 995

user who is not physically capable of taking advantage of its features. Conversely, optimal 996 performance will not be achieved with a prosthesis that does not provide a level of technical 997

sophistication that matches or challenges the user’s physical capabilities. 998

There are significant limitations of the objective clinical knowledge available on the impact of 999 different prosthetic components on performance with a prosthetic leg. Further, it is challenging 1000

to predict an individual’s response to a specific component on clinical variables alone. 1001 Therefore, empiric knowledge and individual judgement remain indispensable to determine the 1002 appropriate prosthetic prescription The measurement and documentation of clinical 1003

performance is recommended. 1004 1005 Choosing between the various components of a prosthetic prescription should be based on 1006

reliable information on the characteristics of these components. Using the product information 1007 provided by the manufacturer alone is insufficient. The determination of the specific 1008

characteristics and functional quality of a prosthesis should be primarily based on clinical and 1009

biomechanical research. It is therefore recommended that prosthetic components be tested in 1010

clinical trials before they come to market. This requires good collaboration between clinicians, 1011 research centres, manufacturers and suppliers. The use of clinically evaluated systems is 1012

recommended. 1013 1014 Guideline #6.2: In their review on the effect of silicone liners, Baars, et al., concluded that 1015 silicone liners seem to lead to better suspension and better walking performance than a 1016

conventional supracondylar socket suspension.127 1017 1018

Updated Evidence: The socket is where the prosthesis and the body connect. It is the most 1019 critical element in prosthetic design. 1020 1021

Unlike the plantar tissues of the intact foot, residual limb soft tissues are not accustom to 1022

bearing loads.128 Loads imparted on the residual limb by the prosthetic socket can cause 1023

wounds and other skin conditions. This is problematic as treatment may require stopping the 1024 use of the prosthesis. To help cushion the transfer of load between the prosthetic socket and 1025 residual limb, soft prosthetic liners have been used. Historically, liners were made from open 1026 and closed cell foams.129 Recently, silicone and other elastomers that roll onto the residual limb 1027 have been used. Some have felt the roll-on liners offer better suspension, durability, and 1028

cushioning than foam.130 1029 1030 Many liners exist on the market.131 The clinician choses a particular liner based on product 1031

23

literature, colleague recommendations, and/or prior experience. There is a growing desire in 1032 the prosthetic field to include scientific evidence when making prescription decisions. A survey 1033

was obtained from a small number of individuals with lower extremity amputation to compare 1034 silicone and Pelite liners. Some preferred the silicone liner because it distributed pressures 1035 differently and had a close connection between the liner and socket. Others rejected the 1036 silicone liner for the same reasons.118 The difference between mineral oil gel liners with 1037 locking pin suspension and Pelite liners with neoprene sleeve suspension were evaluated in a 1038

randomized controlled trial with 13 subjects. The study found that 77% of the subjects 1039 preferred the Pelite system, took 83% more steps and wore the system six hours per day longer 1040 than the gel liner. When interviewed, subjects expressed advantages and disadvantages of both 1041 systems. Both systems performed similarly in terms of pain and comfort.132 1042

1043 In a randomized crossover trial that involved 13 individuals with traumatic amputations, 1044

Coleman et al. found that more steps were taken at a higher intensity with a liner with a pin lock 1045 than with a Pelite liner. However, there was no difference in comfort or satisfaction with the 1046

prostheses.133 In a Dutch RCT involving 36 patients with transtibial amputation, no differences 1047 were found in the outcomes ‘prosthetic function’ and ‘satisfaction’ when comparing a total 1048 surface bearing socket (TSB) or a conventional patellar-tendon bearing (PTB) socket. Although 1049

TSB production is more expensive, PTB sockets require more hours to fit. As a result, the cost 1050 (from a Dutch perspective) is similar for both sockets.134 1051 1052

Prosthetists’ expertise suggests that total contact sockets with proximal ischial or ramus 1053 containment elements have significant improvements in both biomechanical and clinical 1054

outcomes. Stabilization in the sagittal and frontal plane lead to improved gait (including 1055 reduced compensational trunk movements) and relief of the residual bony structures. The 1056 reduction of force on the medial soft tissue areas (the adductor muscles, the adductor tendon, or 1057

the anterior Scarpa triangle) prevents excess force (that can lead to wounds and soft tissue 1058

infection) and enhances blood and lymph circulation. 1059 1060 Guideline #6.3: Patients with a transfemoral amputation using a microprocessor knee, are 1061

better able to walk down a slope.135 1062

1063 Updated Evidence: Microprocessor controlled knee components have been investigated over 1064 the last decade. Independent systematic reviews by Samuellson, et al.,136; Highsmith, et al.,137 1065 suggest that hydraulic microprocessor knees (MPKs) are associated with improved patient 1066 satisfaction, safety, energy consumption, and are cost effective. A systematic review by 1067

Kannenberg, et al.,138 concludes that the benefits of a MPK are also apparent with subjects of 1068 limited mobility. As MPKs vary in type,139-141 different designs maybe associated with 1069 different effects.142, 143 A systematic review by Sawyers, et al., found moderate evidence of 1070

improved confidence, mobility, and decreased cognitive demands. They also concluded that no 1071 evidence could be found where non-microprocessor knees were associated with clinical 1072 advantages over MPKs. Larger observational studies suggest that the benefits of the MPK are 1073 not limited by age, mobility grade, etiology, BMI, and other clinical variables.144, 145 1074

1075 Guideline #6.4: Persons with transtibial level amputation due to trauma walk at a higher speed 1076 with an energy-storing (dynamic response) foot.146 No study was found in which a difference 1077 in patient satisfaction was reported with regard to a specific prosthetic foot.146 1078 1079

24

Updated Evidence: In a Cochrane Review on the effectiveness of ankle foot mechanisms, 1080 Hofstad, et al., concluded that in transtibial amputations, there appears to be greater stride 1081

length with a dynamic response foot in comparison with a conventional fixed prosthetic foot. 1082 At high activity levels, there also seems to be a better gait efficiency.147 1083 1084 Hydraulic and microprocessor controlled feet (MPF) have recently become available in some 1085 countries. Such devices are associated with a reduction of internal stress of the amputated 1086

limb148 and optimize pressure distribution at the residual limb.149 They are also associated with 1087 an increase in minimal toe clearance150, 151 which may contribute to a reduction in the risk of 1088 falling. Patients report feeling safer during ramp descent.152 1089 1090 Guideline #6.5: By using a small pump to create a vacuum a more consistent environment of 1091

negative pressure is produced by drawing the skin and soft tissues to the wall of the socket. 1092

Conceptually by maintaining a constant limb volume control throughout the day, there is no 1093 longer a need for stump socks. Board and colleagues found that positive pressures during stance 1094

phase were significantly lower and negative pressure during swing phase were significantly 1095

greater with the vacuum-assisted socket system (VASS).153 1096

Updated Evidence: Residual volume stability varies among amputees. Some people have little 1097 change in volume whereas others have significant fluctuations during the course of the day. 1098 Designing a socket shape and method of suspension for the potential short- and long-term 1099

changes in residual limb volume has long been a challenge for prosthetists. 1100

1101 Kahle, et al.,154 conclude in their systematic review that the strongest evidence supporting the 1102

clinical outcomes of VASS is residual limb physiology. The mechanical principles of VASS 1103 applied to prosthetic use may have physiological and functional merit. Applying the associated 1104

principles to prosthetic design may create alternative interface design configurations for both 1105

the transtibial amputees and the transfemoral amputees. 1106

1107 Samitier, et al.,155 evaluated 16 individuals with transtibial amputation due to vascular disease 1108

and assessed changes in mobility, balance, risk of falling and satisfaction. Significant 1109 improvements were found in TUG, six minute walk test, four square step tests and Berg Balance 1110 scale. The authors concluded that vacuum-assisted socket systems are useful for improving 1111

balance, gait, and transfers in those with transtibial amputation due to vascular disease over the 1112 age of 50. 1113

1114 Guideline #6.6: Psychosocial consequences of a prosthetic prescription 1115

Updated Evidence: Schaffalitzky156 stresses the importance of psychosocial outcomes in 1116

prosthesis prescription and use. Psychosocial outcomes are as important as physical outcomes. 1117

It is concluded that only limited improvement in physical capabilities may provide important 1118 gains in independence. 1119 1120

1121

25

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