Patient Outcomes After Severe Lower

Extremity Injuries: Limb Salvage vs. Amputation

Lisa Reider, PhD

THE MAJOR EXTREMITY TRAUMA & REHABILITION CONSORTIUM

improving care through collaborative research The goal of METRC is to produce the evidence needed to establish treatment guidelines for the optimal care of the wounded warrior and ultimately improve the clinical, functional and quality of life outcomes of both service members and civilians who sustain major orthopaedic trauma.

WWW.METRC.ORG

METRC Established in 2009 with funding

from the DoD to support a network of 20+ U.S trauma centers, 4 Military Treatment Facilities and one data coordinating center (at Hopkins) to conduct large, multi-center studies addressing treatment and recovery challenges in patients with lower extremity trauma.

Secured over $100 million in funding from the DoD, PCORI & NIH to expand the clinical network and scope of research

Government Steering Committee

Data Standards &Adjudication

Publications

Data Coordinating

Center

Consortium Committee

Consortium Director and Executive Committee

Data Safety Monitoring

Board

Anchor Clinical Sites

(Military & Civilian)

Other Clinical Sites

(Military & Civilian)

Mentoring & Emerging

Investigator

Implementation & Quality

Science

METRC MCC ORGANIZATIONDirector (MacKenzie)

Deputy Director (Castillo)Principal Biostatistician

(Scharfstein)

Associate Director(Frey)

Associate Director (Reider)

COREProtocol Development & Implementation

COREMonitoring, Training & Quality Improvement

COREData Management& Analysis

CORECRF Development & Maintenance

COREInformatics

Chief Operating

Officer(Allen)

METRC ResearchFocus Areas Studies

Early Acute Management PACSPrevention & Treatment of Infection FIXT, BIOBUDEN,

POvIV, OXY, VANCO

Surgical Management to Improve Fracture Healing pTOG, NERVE, OUTLET

Prediction/Prevention of Secondary Conditions METALS II, Long term effects, PRECISE, EMS-BIND, Prevent CLOT

Management of Pain & Psychosocial Factors TCCS, PAINRehabilitation Interventions REPAIR, AlterG,

CBPT

Optimization of Prosthetic & Orthotic Function PRIORITI-MTF,ProFit, TAOS

Research along the care continuum

Cross Cutting Areas: Economic Impact & Cost of Care Measuring Outcomes with PROMIS

Pre hospital management

Acute Care

Rehabilitation

Secondary Outcomes

OUTLET Study

Prospective multi-center observational study comparing 18-month outcomes of patients treated with limb salvage versus early amputation (within 6 weeks of injury) following severe foot & ankle injuries.

We hypothesized that there would be a subgroup of salvage patients who would have had better outcomes had they undergone early amputation

Background

The decision to salvage or amputate severe ankle and foot injuries is still under debate Limb salvage often requires multiple surgeries

to manage soft tissue damage & other injury complications

Significant pain, problems with walking, return to usual activities and in some cases, permanent disability.

No guidelines to inform treatment decisions and it’s unclear who benefits most from an early amputation.

Background

Lower Extremity Assessment Project (LEAP) showed no difference in 2 year outcomes among patients with a bad leg injury treated with limb salvage versus amputation (n=569).

A subset of these patients with open foot and ankle injuries (n=183) that also had significant soft tissue damage reported worse outcomes: Worse self reported function (Sickness Impact

Profile- SIP) More hospital readmissions for complications Longer time to return to full weight bearing

Purpose of the OUTLET Study

Build upon the LEAP sub-study and compare 18 month outcomes of patients undergoing limb salvage versus amputation for treatment of severe foot and ankle injuries.

Identify the injury and patient characteristics that help define the subgroup of patients that would have done better under amputation.

Study Participants

Patients aged 18-60 treated at one of 32 U.S trauma centers for >=1 of following injuries: Pilon fractures Ankle fractures Talus/calcaneus fractures Severe foot crush or blast injuries involving the mid to hind foot

Patients enrolled during initial hospitalization for treatment of their injury.

Injuries had to meet a certain level of severity which can be hard to standardize across surgeons Independently adjudicated by 3 orthopaedic surgeons using xray and

photos to verify eligibility

Outcomes Patients followed at 3, 6, 12 & 18 months post-injury Main study outcomes assessed at 18 months:

Self-reported function using the Short Musculoskeletal Function Assessment (SMFA)

Objective measures of physical performance Secondary Outcomes:

Participation in sports and leisure activities (Paffenbarger Activity Scale)

Return to usual major activities & work productivity

SMFA Validated 46 item questionnaire measuring function in 4

domains (dysfunction index) and the impact of functional deficits (bother index)

Dysfunction index (34 items) Daily activities Arm and hand function Mobility Emotional status

Each domain scored on a scale of 0-100; higher scores= worse function.

No validated MCID; 9 points is considered to be a significant difference.

Physical Performance Agility

Four square step Illinois agility test

Strength Sit to stand Stair ascent

Speed Self selected walk Shuttle run

Physical Performance Tests were selected by an expert panel of PTs

and orthopaedic trauma surgeons Selection criteria:

Easy to conduct in clinic by a trained Coordinator Measures performance at different levels of difficulty

All tests are timed in seconds; faster the time indicates better performance.

Patients who were unable to perform a test due to impairment were included in the analysis as having the worst performance for that given test.

Screened1400

Limb Salvage510

Amputation86

SMFA:67 (78%)

Performance: 58 (67%)

Eligible779

Consented610

Enrolled596 (77%)

Ineligible621

Refused116

Admin withdraw

14

Consent not administered

53

SMFA: 410 (81%)

Performance: 357 (71%)

TAOS Amputation

41

SMFA:20

Performance: 19

SMFA: 87PA: 77

Baseline DemographicsAmputation

(n=112) Salvage(n=510)

Mean Age 40.0 37.7% Male 80% 64%% Non-Hispanic White 71% 68%% Some college 42% 49%% Working Pre-Injury 83% 77%% in Excellent/Very Good Health 71% 62%Mean BMI 29.4 30.1% Current Tobacco User 47% 38%% Non-Extremity ISS > 17 6% 11%

Analysis

Since we can’t randomize patients to limb salvage or amputation, we use a counterfactual approach.

Outcomes observed for salvage patients were compared to the outcomes they would have had, if they had undergone amputation

The analysis uses patient characteristics (i.e. age, co-morbidities, pre-injury function, education) and other injury characteristics (contralateral injuries or injures to other body systems) to impute the outcome of the salvage patients if they had been treated by amputation

Calculate the difference between observed and predicted outcomes

Observed Outcomes: SMFA Scores

Mean SMFA ScoresSMFA Domain

Pop Norm

Salvage Amputation

Dysfunction 12.5 28.9 23.7Mobility 13.6 38.5 29.8Daily Activities

11.8 33.9 28.3

Emotional 20.5 37.4 30.5Hand/Arm 6.0 4.1 4.7

Higher Scores=Worse Function

9 SMFA Points is consider to be a significant difference

Difference in SMFA Score for Patients Treated with Limb Salvage HAD THEY Been Amputated

Observed SMFA score (Under Salvage) –Predicted SMFA score (Under Amputation)

All Patients Pilon/Ankle

Open Mid/Hindfoot

Other Severe Foot

Dysfunction 4.89** 6.11** 4.55** 3.65

Daily activities 5.40 7.00** 4.63 3.96

Mobility 7.97 ** 9.17** 7.71** 6.71**

Emotional status

6.51** 7.04** 6.10** 5.9**

Observed Outcomes: Performance Tests

Median Times (s)Salvage

Time (% impaired)Amputation

Time (% impaired)Four Square Step Test (s) 12.5 (16%) 12.5 (14%

Illinois Agility Test (s) 56.2 (25%) 50.0 (20%)

Sit to Stand Test (s) 14.0 (15%) 12.8 (18%)

Timed Stair Ascent Test (s) 8.5 (20%) 8.0 (15%)

SS Walking Speed (s) 4.5 (11%) 4.0 (10%)

Shuttle Run (s) 35.5 (20%) 32.5 (20%)

All Patients Pilon/Ankle

Mid/Hindfoot

Other Severe foot

Four Square Step Test (s) -1.5 -1.5 -1.5 -1.5

Illinois Agility Test (s) 7.3** 12.0** 9.5** 5.0**

Sit to Stand (s) 1.5 2.3 1.3 1.0 Timed Stair Ascent (s) -1.5 -2.0 -1.0 -1.0

SS Walkingspeed (s) -3.5 -1.0 -1.0 -1.0

Shuttle Run(s) 6.0 ** 12.9** 4.5** 3.3**

Observed Median Time (Under Salvage) –Predicted Time (Under Amputation)

Using regression techniques, we estimated the expected improvement under amputation for salvage patients with these additional characteristics

The following injury characteristics were hypothesized to further impact outcomes: Gustilo type – IIIA,B,C Additional ipsilateral injuries Heel pad degloving Severity of contamination

Impact of Regional Injury Burden

Expected Improvement in SMFA Mobility Open Type III Pilon and IIIB Ankle Fxs if Amputated

Additional Ipsilateral

Ortho Injury

Heel-Pad Degloving

Contamination Expected Improvement Under Amputation

(95% CI)

Yes Yes Yes 13.3 (7.5, 18.5)Yes Yes No 13.5 (7.3, 18.9)Yes No Yes 11.9 (6.8, 17.1)Yes No No 12.1 (6.4, 17.4)

No Yes Yes 10.3 (5, 15.4)No Yes No 10.5 (5, 15.7)No No Yes 8.9 (4.2, 13.8)No No No 9.2 (4.2, 14.3)

Expected Improvement in SMFA Mobility Talus/Calcaneus Fxs if Amputated

Additional Ipsilateral

Ortho Injury

Heel-Pad Degloving

Contamination Expected Improvement Under Amputation

(95% CI)

Yes Yes Yes 10.8 (5.7, 15.8)Yes Yes No 11.1 (5.6, 16.3)Yes No Yes 9.5 (4.6, 14.7)Yes No No 9.7 (4.6, 14.9)

No Yes Yes 7.9 (2.7, 13)No Yes No 8.1 (3, 13.3)No No Yes 6.5 (1.7, 11.7)No No No 6.7 (2, 11.8)

SUMMARY Results suggests that limb salvage patients

with a severe ankle or calcaneus fractures would have had better outcomes had they been amputated Differences are largest among severe pilon/ankle

injuries especially when other ipsilateral injuries and/or heel pad degloving is present

CLINICAL IMPLICATIONS Limb Salvage (even if feasible) might not be the

best option for every patient While these data are not sufficient to generate

patient specific treatment algorithms, they provide a platform for discussions between surgeons and patients related to treatment and expectations for recovery.

Moving in the direction of personalized care.

CLINICAL IMPLICATIONS

These patients (limb salvage and amputees) are still doing poorly 18 months after treatment.

How can we improve outcomes overall? Advances in orthotics (i.e the IDEO brace) Advances in limb prosthetics (ProFit study)

NEXT STEPS

Evaluate secondary outcomes:Return to work/active duty and work

productivity Daily activity using the StepWatchTM activity

monitor

PARTICIPATING CENTERS

Barnes Jewish Hospital, Washington University St. Luke’s Hospital

Carolinas Medical Center St. Vincent's Hospital

Denver Health & Hospital Authority University of Alabama at Birmingham

Duke University Medical Center University of California, San Francisco

Eskenazi Health University of Iowa

Florida Orthopaedic Institute University of Maryland, Shock Trauma Center

Hennepin County Medical Center University of Miami, Ryder Trauma Center

Methodist Hospital University of Mississippi Medical Center

MetroHealth Medical Center University of Oklahoma Medical Center

Naval Medical Center San Diego University of Pennsylvania

New York University, Jamaica Queens University of Pittsburgh

Orlando Regional Medical Center University of Texas Health Science Center, Houston

Orthopaedic Associates of Michigan University of Virginia

Penn State Milton S. Hershey Medical Center University of Washington, Harborview Medical Center

Rhode Island Hospital, Brown University Vanderbilt University

San Antonio Military Medical Center Wake Forest Baptist University Medical Center

St. Louis University Walter Reed National Military Medical Center