DR.MOHAMMED RAEEZ PALAKKALMBBS DORTHO DNB(ORTHO)-JR

WELCOME TO THE JOURNAL CLUBby Metro Hospital

Fracture Clavivle middle third:

IS IT STILL A GREY AREA IN ORTHOPAEDICS?

rough Sx on coservative Conserative mx Pitfalls Surgery traditional indications Changing trends Literature review

Literature proper

Conclusions

General: A clavicular fracture accounts for 2.6%–5 % of adult

fractures

Fractures in the middle-third (OTA 15-B) represent 69%–82% of all clavicular fractures.

There is no consensus among orthopedic surgeons regarding treatment for these fractures:

many support conservative treatment even for displaced middle-third clavicular fractures, while others choose operative treatment.

Treatment Options

Nonoperative Sling Brace

Surgical Plate Fixation Screw or Pin Fixation Ex Fix

Conservative: Simple Sling vs. Figure-of-8 Bandage

Prospective randomized trial of 61 patients

Simple sling Less discomfort

Functional and cosmetic results identical

Alignment of healed fractures unchanged from the initial displacement in both groupsAndersen et al., Acta Orthop Scand 58: 71-4,

1987.

Traditional teaching as indications for surgery…

the absolute indications for surgical treatment include open fractures, fractures associated with skin compromise and neurovascular involement.

CHANGING TRENDS IN MANAGEMENT OF ACUTE CLAVICULAR MIDSHAFT FRACTURES

Traditionally been treated non-operatively, even when substantially displaced

Early reports suggested non-union was extremely rare

4 (0.8%) out of 556 (3.7% with surgery) Rowe CR. An atlas of anatomy and treatment of midclavicular

fractures. CORR 19683 (0.1%) out of 2235 (4.6% with surgery) Neer CS 2nd. Nonunion of the clavicle. JAMA 1960

most important causal factor for nonunion of a midshaft clavicular fracture is improper open surgery

Recent studies on non-operative mx reports: Higher non-union rate (15%)

Higher rate (32%) of unsatisfactory patient outcome Hill et al. Closed treatment of middle-third

clavicle fractures gives poor results. JBJSB 1997There is new evidence that the outcome of non-operative management of displaced middle-third clavicle fractures is not as good as traditionally thought, with many patients having significant functional problems.

Several recent studies reported high union rates with surgical intervention using a variety of

internal fixation devices Ali Khan MA, Lucas HK: Plating of fractures of the

middle third of the clavicle. Injury 1978 Zenni EJ Jr, Krieg JK, Rosen MJ: Open reduction

and internal fixation of clavicular fractures. JBJSA 1981

MOST OF THE STUDIES UNVEILS …

THE LIMITATIONS OF CONSERVATIVE MANAGEMRNT

AND

THE ADVANTAGES OF FIXATION IN A DISPLACED MID THIRD FRX CLAVICLE

Its been proven thatdisplaced midshaft clavicle

fractures can cause significant, persistent

disability, even if they heal uneventfully.

What literature

says…

Nowak J, Holgersson M, Larsson S: Can we predict long-term sequelae after fractures of the clavicle based on initial findings? A prospective study with nine to ten years of follow-up. J Shoulder Elbow Surg 2004

• Prospective study 245 patients with 9-10 years follow-up

Displacement without bony contact, especially with comminuted transverse fracture, and an elderly patients, strongly predictive of long term sequelae and persistent symptoms.

Robinson CM, Court-Brown CM, McQueen MM, Wakefield AE: Estimating the risk of nonunion following non-operative treatment of a clavicular fracture.

J Bone Joint Surg Am 2004

• Prospective review of 581 midshaft clavicular fractures

• 4.5 % non-union rate Fracture displacement, fracture

comminution, female gender, advanced age significantly increase risk of non-union

Wick M, Müller EJ, Kollig E, Muhr G: Midshaft fractures of the clavicle with a shortening of more than 2 cm predispose to nonunion. Arch Orthop Trauma Surg 2001

• Retrospective analysis of 39 clavicle non-union / delayed union

Shortening of 2 cm in midshaft clavicular fractures was associated with an increased risk of pain, limitation of motion, or nonunion

McKee MD et al: Deficits following non-operative treatment

of displaced midshaft clavicular fractures. J Bone Joint Surg Am 2006

• Prospective study of 30 cases with displaced midshaft clavicle #s (mean follow-up 55 months)

• assessed functional outcome and noted significantly inferior scores for both the upper extremity–specific (DASH) outcome scores and the Constant scores compared with the general population.

fractures with >2 cm of shortening tended to be associated with decreased abduction strength and greater patient dissatisfaction

Deficits following nonoperative treatment of displaced midshaft clavicular fractures The strength of the injured shoulder was 81% for

maximum flexion, 75% for endurance of flexion, 82% for maximum abduction, 67% for endurance of abduction, 81% for maximum external rotation, 82% for endurance of external rotation, 85% for maximum internal rotation, and 78% for endurance of internal rotation (p < 0.05 for all).

The mean Constant score was 71 points, and the mean DASH score was 24.6 points, indicating substantial residual disability.

McKee et al. J Bone Joint Surg Am 2006;88-A:35-40.

Hill JM, McGuire MH, Crosby LA: Closed treatment of displaced middle third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997

• Retrospective review of 52 midshaft clavicular fractures

final shortening ≥2 cm was associated with an unsatisfactory result but not with non-union

Ledger M, Leeks N, Ackland T, Wang A: Short malunions of the clavicle: An anatomic and

functional study.J Shoulder Elbow Surg 2005

• Evaluated the effects of clavicular malunion (15mm shortening) in 10 subjects using CT with 3D recon, shoulder score assessments and biomechanical testing

Significant increase in upward angulation of the SC joint and an increased scapular version compared with the uninjured side

Significantly weaker muscle strength than that of the uninjured arm

Significant poorer shoulder scores outcome

These studies indicate that although clavicular deformities are complex and hard to assess, shortening of 1.5 to 2 cm results in an increased incidence of clinical symptoms

Moving on to the journal under study…

Yaron S. Brin MD, Ezequiel Palmanovich MD, Eran Dolev MD, Meir Nyska MD and Benyamin J. Kish MD Department of Orthopedic Surgery, Meir Medical Center, Kfar Saba, affiliated with Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Displaced Mid-Shaft Clavicular Fractures: Is Conservative Treatment Still Preferred?

Objectives: To assess the attitudes of orthopedic surgeons regarding treatment of displaced mid-shaft clavicular fractures

Traditionally.. the absolute indications for surgical treatment

include open fractures, fractures associated with skin compromise and neurovascular involement.

Conservative treatment for these fractures was the common practice since older studies claimed the non-union rate to be less than 1%

A certain amount of deformity with return of satisfactory function of the shoulder was expe…….

Several recent studies reported worse results with conservative treatment:

a non-union rate of 15–20% shoulder muscle strength loss of 18–

33% poor early functioning of the injured

shoulder and as many as 42% of patients with

residual sequelae 6 months after injury

Since this injury occurs most often in young active patients who want to avoid the above complications, primary operative treatment has become common.

Several fixation treatments are used, such as

intramedullary nail plate and screws and a locking plate and screws Ex fix devices

Numerous randomized studies comparing conservative to operative treatment have been conducted Xu et al and McKee et al performed a

meta-analysis to determine the preferred treatment.

They found a higher non-union rate and symptomatic mal-union rate after conservative treatment.

It seems that the traditional guidelines for operative treatment of the displaced mid-shaft clavicular fracture are less strict than in the past.

Guidelines in many medical fields change with time, and the emergence of new technologies mandates expert opinion

In this paper we review the literature and determine the current trends and common practices for treating a displaced mid-shaft clavicular fracture

METHODS We developed a multiple-choice

questionnaire on displaced mid-shaft clavicular fractures

X-rays were included

The questionnaires were distributed to orthopedic surgeons during the 13 EFORT meeting in Berlin, Germany in May 2012.

Figure : X-ray of a 50 year old healthy active patient admitted to the emergency room with a closed injury. Physical examination revealed no neurovascular injury and no skin tenting

The first question The first question addressed the

preferred treatment option for a displaced mid-shaft clavicular fracture (OTA 15-B1) that was shown on an X-ray

Possible response was conservative or operative

The second question The second question addressed

the preferred operative technique for fixation of the illustrated fracture.

The choices were non-locking plate and screw, a locking plate and screw, or an intramedullary nail.

third question The third question related to the

experience of the surgeons with operative treatment of displaced mid-shaft clavicular fractures.

They were asked to report how many displaced mid-shaft clavicular fractures they had operated on the year before.

Statistical analysis A univariate analysis was performed using

the chi-square test to detect significant differences in choices among surgeons from different subspecialties and with varying levels of experience. Data were presented as numbers and percentages. Differences between selected subspecialties were compared using the chi-square test.

A P value of < 0.05 was considered statistically significant.

Question 1177 surgeons responded: 50.6% chose conservative treatment49.4% recommended operative treatment. Among the trauma specialists:58% suggested operative treatment (P = 0.033).

Among shoulder specialists:82% preferring operative treatment (P = 0.046).

Question 2 177 surgeons responded: 37% chose a

non-locking plate, 49% chose a locking plate, and 14% chose an intramedullary nail.

Orthopedic trauma specialists and shoulder specialists answered this question with approximately the same distribution.

Question 3From the total population of surgeons who participated in the survey:

36% had not operated on clavicle fractures in the last year, 38% had operated on up to 5 cases, and 15% operated on 6–10 cases.

Only 11% had operated on more than 10 cases in the last year.

These included :15% of the trauma specialists, 6.5% of the non-trauma or shoulder specialists, and20% of the shoulder specialists

Discussion:Conservative vs. operative treatment

Most mid-shaft clavicular fractures can be treated conservatively.

These include:

- children and adolescents with a greater chance of healing because of delayed closure of the medial epiphysis

-simple or multi-fragmentary fractures with minimal displacement,and

-patients with high risk for low compliance

During the 1960s, mid-clavicular fractures were considered the domain of non-operative treatment, based on two studies conducted by :

Neer and Rowe

Regardless of fracture type and displacement, complete recovery of shoulder function was anticipated

Pitfalls of study favouring conservative Rx..

There are several reasons for discrepancies between those

studies and newer studies that support operative over conservative treatment.

One is the patients’ expectations of treatment results. Osseous consolidation and range of motion, which were the main considerations for treatment success in the past, are not the only factors today.

Patient-based scoring systems (Constant Score and DASH Score) also

consider factors such as pain, cosmetic result and daily function.

Constant Shoulder Score Pain Activity level Arm positioning Strength of abduction in pounds ROM

Foreward flexion Lateral elevation External rotation Internal rotation

Grading the Constant Shoulder Score(Difference between normal and Abnormal Side)

>30 Poor21-30 Fair

11-20 Good<11 Excellent

The Disabilities of the Arm, Shoulder and Hand (DASH) Score

Neer and Rowe concluded in their well-known studies that

conservative treatment is good enough, since both included in their series a large number of adolescents.

The clavicle has a great potential for remodeling at those ages due to late closure of its diaphysis.

Conservative treatment is sufficient for young patients but should not be the treatment of choice in older patients.

Only in 1998 was a new classification described that took into account the degree of displacement and

comminution.

With the newer classification, devised by Robinson ,a suitable treatment can be assigned according to fracture type.

Abstract Background: There is a growing trend to treat displaced midshaft clavicular fractures with primary open reduction and

plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment.

Methods: In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed.

Results: The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001).

Conclusions: Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.

Mal-union is one of the factors that cause

reduced shoulder function.

It was noted recently that displaced mid-shaft clavicular fractures have a high rate of mal-union, non-union, and sequelae.

Robinson noted four risk factors for the above complications: age, female gender, displacement of more than one clavicular shaft width, and comminution

Displaced mid-shaft clavicular fractures might be complicated with mal-union and non-union in 19-33% of cases.

When the fracture is comminuted, the rate of mal-union and non-union increases to between 33% and 47%

Several recent studies stressed the importance of clavicular length restoration.

They showed that clavicular shortening of more than 15 mm following healing caused a higher incidence of pain.

33% of patients were dissatisfied after treatment for displaced mid-shaft clavicular fractures that resulted in shortening.

Strength reduction was also noted in shoulder flexion, abduction and rotation.

Robinson reported a higher dissatisfaction rate in patients treated conservatively for displaced mid-shaft clavicular fractures .

These findings have led to the tendency to operate even on adolescents when the fracture is completely displaced or when the length of the clavicle cannot be restored

.

Of the surgeons who took part in this study, 49.4% felt that operative treatment is the preferred option for this injury.

Interestingly, among trauma specialists and shoulder specialists (the surgeons who treat these injuries most often), the proportion of surgeons who prefer operative treatment was much higher.

Conclusions

According to our survey results there is still no consensus regarding conservative vs. operative treatment for a displaced mid-shaft clavicular fracture.

Orthopedic trauma specialists and shoulder specialists have a greater propensity toward operative treatment.

Most surgeons who operate on these fractures prefer to use a locking plate as a fixation system.

Still another one…

 Andrew H. Schmidt, MD, 

professor of orthopedic surgery at the University of Minnesota, and director of orthopedic research at Hennepin County Medical Center

Dr. Schmidt presented “Clavicle Fractures: Which Ones Really Should

Be Operated On?” during the 2014 AAOS Annual Meeting in New Orleans.

Andrew H. Schmidt, MD

According to Dr. Schmidt, a 1997 study was first to challenge the belief that all clavicle fractures heal well with conservative treatment.

The authors evaluated 3-year outcomes of 52 displaced midshaft clavicle fractures treated nonsurgically.

“They found that 31 % of patients with initial shortening of more than 2 cm reported poor functional outcomes, and 15% of the fractures developed nonunions,” he said.

These findings were supported by a similar study published in 2006 that documented the functional deficits of 30 patients after nonsurgical care of a displaced midshaft clavicle fracture.

At a minimum 12-month follow-up (mean = 55 months),

Constant and Disabilities of the Arm, Shoulder and Hand (DASH) scores indicated substantial residual disability.

“All shoulders had deficits in muscle strength, compared to the noninjured shoulder,” Dr. Schmidt said.

Published in 2013, the study found that 99 percent of fractures in the surgical group healed, compared to 74 percent in the nonsurgical group, but that half of the nonunions were asymptomatic.

Also in 2013, the Cochrane Collaboration reviewed eight randomized trials involving 555 participants with middle third clavicle fractures.

Four studies compared plate fixation to

nonsurgical treatment;

the other four studies compared intramedullary nails to nonsurgical treatment.

The authors concluded, that evidence in favor of surgical versus nonsurgical treatment for these fractures was insufficient and that treatment options must be chosen on an individual patient basis, after careful consideration of the relative benefits and harms of each intervention and of patient preferences

He added that studies have shown that early ORIF reduces the nonunion rate from 15% to 2 % or less and also

reduces the symptomatic malunion rate from 20 % to 2 % or less.

However, most patients whose fractures are treated nonsurgically have acceptable functional outcomes.

“Nonetheless, evidence exists to support early surgical intervention for select midshaft clavicle fractures. ORIF speeds up healing in high-demand patients and is a consideration in the worker or athlete,” he said.

Still another…

“Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures”

Sahal A. Altamimi, MD, FRCS(C); Michael D. McKee, MD, FRCS(C)

J Bone Joint Surg Am, 2008 Mar; 90 

A high prevalence of symptomatic malunion and nonunion after nonoperative treatment of displaced midshaft clavicular fractures.

compared patient-oriented outcome and complication rates following nonoperative treatment and those after plate fixation of displaced midshaft clavicular fractures.

METHODS:  In a multicenter, prospective clinical trial, 132 patients with

a displaced midshaft fracture of the clavicle were randomized (by sealed envelope) to either operative treatment with plate fixation (67 pts) or nonoperative treatment with a sling (65 pts).

Outcome analysis included standard clinical follow-up and the Constant shoulder score, the Disabilities of the Arm, Shoulder and Hand (DASH) score, and plain radiographs.

111 patients (62 managed operatively and 49 managed

nonoperatively) completed one year of follow-up.

There were no differences between the two groups with respect to patient demographics, mechanism of injury, associated injuries, Injury Severity Score, or fracture pattern.

RESULTS: Constant shoulder scores and DASH scores were significantly improved in the operative fixation group at all time-points (p = 0.001 and p < 0.01, respectively).

The mean time to radiographic union was 28.4 weeks in the nonoperative group compared with 16.4 weeks in the operative group (p = 0.001).

There were 2 nonunions in the operative group compared with 7 in the nonoperative group (p = 0.042).

Symptomatic malunion developed in 9 patients in the nonoperative group and in none in the operative group (p = 0.001).

CONSERVATIVE GROUP

OPERATED GROUP

MEAN TIME OF RADIOGRAPHIC

UNION

28.4 WEEKS 16.4 WEEKS

NON-UNIONS 7 2

MALUNIONS 9 NONE

At one year after the injury, the patients in the operative group were more likely to be satisfied with the appearance of the shoulder (p = 0.001) and with the shoulder in general (p = 0.002) than were those in the nonoperative group.

CONCLUSIONS: Operative fixation of a displaced fracture of the

clavicular shaft results in improved functional outcome and a lower rate of malunion and nonunion compared with nonoperative treatment at one year of follow-up.

Hardware removal remains the most common reason for repeat intervention in the operative group.

This study supports primary plate

fixation of completely displaced midshaft clavicular fractures in active

adult patients.

CRITICAL CONCEPTS INDICATIONS: The majority of clavicular fractures can be treated effectively with nonoperative means. Operative fixation is indicated in healthy, physically active individuals between the ages of sixteen and sixty years with any of the following: • A completely displaced midshaft fracture with shortening of >2 cm • Superior displacement with skin tenting and/or an impending open fracture • An associated neurovascular injury • An open clavicular fracture • A floating shoulder with a completely displaced clavicular fracture • An obvious clinical deformity with shoulder asymmetry (a combination of shortening, rotation, and displacement) • Multiple injuries with any of the above indications

CONTRAINDICATIONS: • Active infection in the operative area • Prior soft-tissue irradiation in the operative area • Burns over the clavicular area • Debilitating medical conditions • A high risk of poor patient compliance, especially due to substance abuse (drugs and/or alcohol) • An elderly patient with a sedentary lifestyle

POSTOPERATIVE CARE

The arm is maintained in a sling on a full-time basis for two weeks, after which use of the sling is discontinued and active assisted range-of-motion exercises of the shoulder in the scapular plane are begun. Full active motion is initiated at four weeks. When clinical and radiographic signs of union are present, strengthening and resistive exercises of the rotator cuff, deltoid, and trapezius are begun, usually at six to eight weeks. By three to four months, most patients are allowed to participate in all sports activities.

PITFALLS: • Preoperative planning and patient selection are crucial. Patients at high risk for multiple falls, alcohol abuse, or noncompliance may have early mechanical failure of the fixation and are not candidates for this procedure. • Failure to carefully contour the plate to accommodate the s-shape of the clavicle can lead to implant prominence and softtissue irritation at the ends of the plate. The use of a precontoured anatomic plate helps to decrease soft-tissue irritation. • A minimum of three 3.5-mm screws should be placed in each of the proximal and distal fragments, and ideally the plate should be applied in compression mode to reduce the risk of delayed union or nonunion. • Cautious drilling, especially when sharp drills and taps are used, is of paramount importance in this procedure. A blunt retractor placed under the clavicle, which adds undesired soft-tissue dissection, can be used if necessary. We have found that this step is not required as experience increases. • The intervening fragments should not be stripped. They should be teased into position, with preservation of soft-tissue attachments and ensuring that the length and rotation of the clavicle are correct. • A postoperative chest radiograph is required only in rare circumstances where a pleural injury is suspected.

ABSTRACT We evaluated 242 consecutive fractures of the clavicle in adults which had been treated conservatively. Of these, 66 (27%) were originally in the middle third of the clavicle and had been completely displaced. We reviewed 52 of these patients at a mean of 38 months after injury. Eight of the 52 fractures (15%) had developed nonunion, and 16 patients (31%) reported unsatisfactory results. Thirteen patients had mild to moderate residual pain and 15 had some evidence of brachial plexus irritation. Of the 28 who had cosmetic complaints, only 11 considered accepting corrective surgery. No patient had significant impairment of range of movement or shoulder strength as a result of the injury. We found that initial shortening at the fracture of > or = 20 mm had a highly significant association with nonunion (p < 0.0001) and the chance of an unsatisfactory result. Final shortening of 20 mm or more was associated with an unsatisfactory result, but not with nonunion. No other patient variable, treatment factor, or fracture characteristic had a significant effect on outcome. We now recommend open reduction and internal fixation of severely displaced fractures of the middle third of the clavicle in adult patients.

St. Charles Hospital, Port Jefferson, New York, United States Journal of Shoulder and Elbow Surgery (Impact Factor: 2.37). 03/2006; 15(2):191-

4. DOI: 10.1016/j.jse.2005.08.007 Source: PubMed ABSTRACT Fractures of the clavicle are common and most often occur in the

middle third. The clavicle has several important functions, each of which may be affected after fracture and malunion. In this retrospective study, we reviewed 132 patients with united fractures of the middle third of the clavicle after conservative management. Residual symptoms and overall patient satisfaction after treatment were assessed through a questionnaire. Clavicular shortening after union was calculated on a standardized anteroposterior chest radiograph. Intraobserver variability and interobserver variability of measurements by use of this method are insignificant. The mean follow-up was 30 months (range, 12-43 months). The mean modified Constant score was 84 (range, 62-100). Of the patients, 34 (25.8%) were dissatisfied with the result of their management. Final clavicular shortening of more than 18 mm in male patients and of more than 14 mm in female patients was significantly associated with an unsatisfactory result.

Displaced Fractures of the Clavicle: Who Should Be Fixed?

Commentary on an article by C.M. Robinson, FRCSEd(Tr&Orth) et al.: “Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures. A Multicenter, Randomized, Controlled Trial”

Michael D. McKee, MD, FRCS(C)J Bone Joint Surg Am, 2013 Sep 04; 95 (17): e129 .

http://dx.doi.org/10.2106/JBJS.M.00527

CommentaryThis study is yet another high-quality, well-

designed, and robust (N = 200) randomized clinical trial from a group of investigators who are well recognized for their contributions to evidence-based medicine in the field of orthopaedics. There has been increasing interest in the primary fixation of displaced midshaft fractures of the clavicle since the landmark article by Hill et al., published in 1997, describing a high rate of dissatisfaction following the nonoperative

treatment of these injuries1. In the current study, Robinson et al. randomized such individuals to primary plate fixation or a collar and cuff for three weeks. The study design and the inclusion/exclusion criteria (with the study group comprising active healthy patients sixteen to sixty years of age with completely displaced fractures) are nearly identical to those in a number of other recent randomized clinical trials, most of which concluded that primary operative fixation was beneficial for patients2-5. The reader may be justifiably confused by Robinson and colleagues’ conclusion that their results do not support primary plate fixation for these injuries. However, in my opinion, the results of these studies are very similar and complementary, not contradictory, and some clear facts emerge

First, the rate of delayed and nonunion is high after the nonoperative treatment of displaced midshaft clavicular fractures. Robinson reported that twenty-four (26%) of ninety-two patients in the nonoperative treatment group were not healed at six months and that seventeen (18%) eventually underwent reconstructive surgery (thirteen for the treatment of nonunion and four for the treatment of malunion). This finding is consistent with those in the other randomized trials on this topic

Second, primary fixation with a plate is a safe, reproducible operative technique, within the technical grasp of most orthopaedic surgeons, that dramatically lowers the nonunion rate compared with nonoperative care. In the study by Robinson et al., there was only one nonunion after eighty-six operative procedures, for a rate of 1%, representing a relative risk reduction for nonunion of 93% compared with the nonoperative treatment group (p = 0.007). This finding is nearly identical to those of the other published trials2-4.

Third, the major complication rate following plate fixation is low, and the most common reason for reoperation is hardware removal. Ten patients in the current series had plate removal because of local irritation, which again was consistent with the findings of other studies.

Fourth, in general, there are modest improvements in functional outcome (5 to 10 points on a 100-point scale such as the Constant shoulder score) following operative fixation that are especially evident in the early postinjury period. The magnitude and time course of this improvement do vary between studies (roughly a 5-point improvement in Constant scores in the operative treatment group at one year in the study by Robinson et al. compared with 11 points in another similar study2). Other studies have demonstrated earlier return to work and sports following operative repair; however, this was not evident in the report by Robinson et al.

Fifth, many, if not most, patients with a displaced midshaft fracture of the clavicle will respond relatively well to nonoperative care, and the “number needed to treat” (NNT) to avoid a specific negative outcome such as nonunion is high. For example, Robinson et al. calculated that it would be necessary to treat 6.2 fractures with primary plate fixation in order to prevent one nonunion. A recent meta-analysis demonstrated a slightly lower NNT of 4.6 for both

nonunion and symptomatic malunion4. It is clear that refined prognostic criteria that allow the surgeon to recognize patients who are at high risk for nonunion or symptomatic malunion would result in a focusing of surgical resources on such individuals, decreasing unnecessary procedures and lowering the NNT substantially. Practically speaking, it can be argued that increasing degrees of fracture displacement or shoulder deformity, with increasing functional demands, warrant a more aggressive approach to primary fixation. Robinson et al. point out that, in their series, it was typically the sixteen to thirty-year-old active male who most often opted for surgery when the risks and benefits were explained.

Sixth, in a similar vein, there are as yet undetermined factors affecting outcome following these injuries, including cultural responses to pain and disability, that may explain differences in results. For example, in the Finnish study by Virtanen et al., the nonunion rate following nonoperative treatment was 24%, yet few of those patients sought surgical reconstruction3. The North American literature suggests that surgical repair of the nonunion would be sought by most such individuals.

In summary, the information from this important study can be added to the growing library of evidence-based data that the practicing orthopaedic surgeon can use in the day-to-day treatment of displaced midshaft fractures of the clavicle. In contrast to the rudimentary responses of the past, we now have extensive knowledge with which to answer our patients’ questions and concerns. It is important that we use this information in a clear, nonbiased fashion to assist our patients in making the appropriate therapeutic choice for their displaced midshaft clavicular fracture.

Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures

A Multicenter, Randomized, Controlled Trial C.M. Robinson, FRCSEd(Tr&Orth); E.B. Goudie, BMedSci(H

ons), MRCSEd; I.R. Murray, BMedSci(Hons), MRCSEd, Dip SEM; P.J. Jenkins, FRCSEd(Tr&Orth); M.A. Ahktar, MRCSEd; E.O. Read, BMedSci(Hons);C.J. Foster, MBChB; K. Clark, BSc; A.J. Brooksbank, FRCS(Tr&Orth); A. Arthur, FRCS(Tr&Orth); M.A.Crowther, FRCS(Tr&Orth); I. Packham, BMBS, BMedSci, FRCS(Tr&Orth); T.J. Chesser, FRCS(Tr&Orth)

J Bone Joint Surg Am, 2013 Sep 04; 95 (17): 1576 -1584 . http://dx.doi.org/10.2106/JBJS.L.00307

AbstractBackground: There is a growing trend to treat

displaced midshaft clavicular fractures with primary open reduction and plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment.

Methods: In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed.

Results: The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001).

Conclusions: Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.

Fractures of the ClavicleL.A. Kashif Khan, BSc(Hons),

MRCSEd; Timothy J. Bradnock, BSc(Hons), MRCSEd; Caroline Scott,MBChB; C. Michael Robinson, BMedSci, FRCSEd(Orth)

J Bone Joint Surg Am, 2009 Feb 01; 91 (2): 447 -460 . http://dx.doi.org/10.2106/JBJS.H.00034

Nonoperative Treatment Many conservative treatment methods have been described32, but the

simple sling and the so-called figure-of-eight bandage have been used most widely. A comparative study demonstrated better patient satisfaction with the simple sling, and the functional and cosmetic results of the two treatment methods were identical24. Neither technique reduces a displaced fracture24, but the risk of axillary pressure sores, compression of the neurovascular bundle, and nonunion are higher in patients treated with the figure-of-eight bandage13,20,24,27,33-35. For this reason, the simple sling is most commonly used. Use of the sling can normally be discontinued once the acute pain has subsided, and patients are encouraged to undertake normal activities as pain allows. Recovery of the range of motion and function of the shoulder is usually swift if the fracture unites, and supervised physiotherapy is only rarely required. Most patients respond well to a simple self-administered program of range-of-motion and muscle-strengthening exercises.

A recent multicenter trial comparing nonoperative treatment with primary plate fixation for displaced fractures in 138 patients demonstrated better functional outcomes, lower rates of malunion and nonunion, and a shorter time to union in the latter group29. However, the operative group had a complication rate of 34% and a reoperation rate of 18%, although most reoperations were for hardware removal. The two validated functional scores that were reported showed a small but significant benefit from plate fixation (p = 0.001 for the Constant score46 and p < 0.01 for the Disabilities of the Arm, Shoulder and Hand [DASH] score47). However, the poorer overall scores in the nonoperative group may have been due to a minority of outlying patients with poor scores due to nonunion. It was unclear whether any distinct functional benefit was gained from the operative treatment in the patients with a healed fracture as compared with the outcome in those in whom the fracture healed after nonoperative treatment. The authors stated that their results supported the use of primary plate fixation of displaced fractures in active adults. However, this interpretation may lead to overtreatment, as a number-needed-to-treat analysis revealed that operative fixation of nine fractures would be required to prevent one nonunion, and fixation of 3.3 fractures would be required to prevent one symptomatic malunion or nonunion48

A recent study49 comparing acute operative treatment of midshaft fractures with delayed treatment of established nonunions and malunions showed no significant difference in the DASH score and a significant difference (p = 0.05) in only one of six strength and endurance variables that were tested. There was a significant difference (p = 0.02) of 6 points in the Constant score, but all patients reported a high level of satisfaction.

As yet, there is no firm consensus regarding which displaced fractures should be treated operatively. Many younger patients now seek operative treatment in the hope of obtaining a better functional outcome and an earlier return to contact sports. It is our opinion that these patients should be offered the option of operative treatment, after they have been adequately counseled regarding the risks involved and the likely outcome of that treatment.

Operative Techniques

A wide variety of methods have been described for operative fixation of shaft fractures (seeAppendix)21,29,36,38,50-67.

Plate Fixation This technique provides immediate rigid stabilization and pain relief and

facilitates early mobilization7,39,42,44,45,68. Most commonly, the plate is implanted on the superior aspect of the clavicle, and biomechanical studies have shown this to be advantageous, especially in the presence of inferior cortical comminution69. However, the approach is associated with a greater risk of injury to the underlying neurovascular structures during fracture manipulation and drilling, and subsequent prominence of the plate may necessitate its removal. In an attempt to address these problems, an anterior-inferior approach to allow inferior implantation of the plate was developed. This technique was associated with a low complication rate in a series of fifty-eight patients65, although biomechanical testing has suggested that a superior position of the plate provides more secure fixation6

Currently, the implants most commonly used are either dynamic compression or locking plates. Reconstruction plates have fallen into disfavor, since they are susceptible to deformation at the fracture site, leading to malunion. Site-specific precontoured locking plates have recently been introduced, and they may be less prominent after healing, leading to lower rates of hardware removal after union29,71. There is now also the option of locking screws into these plates, to improve the fixation of fractures that extend into the lateral end of the clavicle and of those in elderly patients with osteoporotic bone. The efficacy of these implants has not yet been fully tested in comparative clinical studies. The complications related to the use of plate fixation are infection36, plate failure36, hypertrophic or dysesthetic scars72, implant loosening36,73, nonunion63, refracture after plate removal36,63,73, and very rarely intraoperative vascular injury74.

Intramedullary Fixation The sigmoid shape of the clavicle poses specific problems in the design

and insertion of intramedullary devices, and static locking is not possible with the implants that are currently available. The nail must be narrow and flexible enough to pass through the narrow medullary canal and sigmoid curvature of the clavicle, yet strong enough to withstand the forces acting on the fracture until it unites21,75,76. There is biomechanical evidence to suggest that plate fixation provides a stronger construct than intramedullary fixation77. A variety of devices, including Knowles pins38,57, Hagie pins, Rockwood pins, and minimally invasive titanium nails, have been used54. Two methods of implant insertion have been described: antegrade, through an anteromedial entry point in the medial fragment, and retrograde, through a posterolateral entry portal in the lateral fragment. As a result of the narrow medullary canal, the fracture site must usually be opened through a separate incision to expose the proximal and distal parts of the canal for implant insertion.

The reported results have been more mixed than those after plate fixation38,53,57, and the inability to statically lock these implants may lead to shortening, especially if there is comminution. High rates of implant breakage, temporary brachial plexus palsy, and skin breakdown over the entry portal have also been reported with the use of these techniques78,79. Intramedullary fixation is therefore used less widely than plate fixation, although proponents of the technique suggest that the more minimally invasive approach offers advantages for patients with multiple injuries or other shoulder girdle injuries54.

Other TechniquesExternal fixators have been used to treat clavicular

fractures, although this technique is most commonly recommended only for open fractures or septic nonunions80. Kirschner wires have been advocated to maintain reduction, but numerous reports have described complications arising as a result of wire breakage and migration to a variety of anatomic locations, with potentially catastrophic consequences42,81. The use of these implants in the management of clavicular fractures is therefore strongly discouraged.

Complications of Operative TreatmentThe main potential intraoperative complication is

injury to the subclavian artery or vein at the time of fracture mobilization or from drill penetration. The risk of this complication should be very low, but it may necessitate vascular or cardiothoracic surgical intervention. Postoperative wound complications, scar dysesthesia, infection, fixation failure, and nonunion are relatively common and may require revision surgery, as does any other failed osteosynthesis.

Overview and Recommendations There is a general consensus that undisplaced clavicular fractures are best

treated nonoperatively. The paucity of Level-I and II evidence makes it difficult to produce concrete guidelines for the treatment of displaced clavicular fractures (Table III). Operative reconstructions of diaphyseal nonunions have good outcomes, and the large number of case series documenting consistently satisfactory outcomes after plate fixation lends support to the use of this technique as the treatment of choice (Grade-B recommendation). Although good outcomes have been reported after operative treatment of acute diaphyseal and lateral-end fractures, it is difficult to predict which patients should be offered primary operative reconstruction and which technique should be used (Grade-C recommendation). Although the results of a recent multicenter study lend support to the use of primary operative intervention for diaphyseal fractures29, the magnitude of the treatment effect may be insufficient to justify offering surgery to all patients with this injury. Independent validation from other multicenter studies is required before the widespread use of this technique can be recommended (Grade-C recommendation).

Researchs

Stanley and Norris reviewed a consecutive series of 140 patients with fractures of the clavicle. All had been treated with either a figure-of-eight bandage or a sling. There was no difference in either the rate or speed of recovery between the groups.

Stanley D, Norris SH. Recovery following fractures of the clavicle treated conservatively. Injury 1988;19:162-164

Researchs Hill et al:

Evaluated 242 adult clavicle fractures treated closed 66 (27%) completely displaced middle third Nonunion 8/52=15%. Unsatisfactory result 16/52=31% Mild-moderate pain 13/52=25%. Brachial plexus irritation

15/52=29% Cosmetic complaints 28/52 with 11/52 considered corrective

surgery Initial shortening at fracture of > 2cm had a significant

association with nonunion and chance of unsatisfactory result

Recommended ORIF of severely displaced fractures of the middle third of the clavicle in adult patients

Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997;79:537–539.

Researchs

Wick et al: clavicle fractures with greater than 20 mm of shortening were highly predisposed to develop a nonunion. Of middle third clavicle nonunions in their series, 91% (30/33) were shortened by at least 2 cm.

Wick M, Muller EJ, Kollig E, et al. Midshaft fractures of the clavicle with a shortening of more than 2 cm predispose to nonunion. Arch Orthop Trauma Surg 2001;121(4):207-211

Researchs

Thompson reviewed more than 100 middle-third clavicular nonunions reported in the literature and found that 90% of the original fractures had displacement greater than 100%, overriding more than 1 cm, or had severe comminution .

Thompson JS. Operative Treatment of Certain Clavicle Fractures. An Orthopaedic Controversy. Orthop Trans 1988;12:141

Operative Treatment Indications of operative treatment

Absolute Unstable Group II fxs (Type IIA, Type IIB, Type V).  Open fxs. Widely displaced >= 2 cm: increased risk for

nonunion. Displaced fx with skin tenting, hypertrophic callus. Subclavian artery or vein injury. Floating shoulder (clavicle and scapula neck fx). Symptomatic nonunion. Posteriorly displaced Group III fxs. Displaced Group I (middle third).  Thoracic outlet.

Indications of operative treatment (con.)

Fracture that threaten the overlying skin Bilateral clavicle fxs. With multiple ipsilateral rib fractures

Relative and controversial indications

- Brachial plexus injury.- Closed head injury. - Seizure disorder. - Polytrauma patient.

- Contraindications of operative treatment

Non-displaced fractures (no comminution , <3mm displacement)

Infection Elderly, low-demand, high surgical risk patients

Stabilization techniques include Plate fixation Intramedullary fixation External fixation Coracoclavicular ligament repair or reconstruction

in Group II Postoperative rehabilitation

Sling for 7-10 days followed by active motion Strengthening at ~ 6 weeks when pain free

motion and radiographic evidence of union Full activity including sports at ~ 3 months

Int J Shoulder Surg. 2009 Apr-Jun; 3(2): 23–27. doi:  10.4103/0973-6042.57895 PMCID: PMC2904537 Treatment of mid-shaft clavicle fractures: A comparative study David S. Thyagarajan, Marion Day, Colin Dent, Rhys Williams, and Richard Evans Author information ► Copyright and License information ► This article has been cited by other articles in PMC. Go to: Abstract We retrospectively evaluated 51 patients (17 in each of three groups) with mid shaft

clavicle fractures. Group 1 underwent intramedullary stabilization using clavicle pins. Group 2 underwent open reduction and internal fixation using plates and group 3 underwent non operative treatment with a sling. Group1 patients progressed to union within 8 to 12 weeks. In Group 2, six patients had scar related pain and two had prominent metal work and discomfort and in group 3, three patients developed non union and one had symptomatic malunion. Our results suggest that the displaced and shortened midshaft clavicle fractures require operative fixation and the techniques of clavicle pinning resulted in less complications, short hospital stay and good functional outcome.

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