Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

Study Overview
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Brief Summary
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The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.

Detailed Description
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Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.

Official Title
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Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

Conditions
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Sarcoma, Bone Metastases, Proximal Femur Replacement

Intervention / Treatment
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* Procedure: Proximal Femur Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon Exclusion Criteria: Non-ambulatory before or after the procedure Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Proximal Femur Replacement<br>The proximal femur is a common site for primary bone sarcomas and metastatic disease. The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. | Procedure: Proximal Femur Replacement<br>* The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Musculoskeletal Tumor Society (MSTS) score | The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function. | up to 24 months postoperatively | 
| Harris Hip Score | The Harris Hip Score (HHS) is a clinician-based outcome measure that is frequently used for the evaluation of patients following a Total Hip Arthroplasty (THA). The survey has ten questions and scores ranging from 0-100, with higher scores representing less dysfunction and better outcomes. | up to 24 months postoperatively | 
| Number of patients with an implant-related complication as reported on the adverse event form upon participation completion. | The adverse event form records the occurence of implant-related complications that occur during study participation. | up to 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Analysis as reported on the study's case report form | Motion data collected from gait analysis testing will be evaluated with OpenCap. | up to 24 months postoperatively |