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

Recruiting

• Conditions: Proximal Femur Replacement; Sarcoma; Bone Metastases
• Interventions: Procedure: Proximal Femur Replacement

• Registration Number: NCT03261544
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2017-11-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2027-06
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proximal Femur Replacement	Proximal Femur Replacement	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.

Primary Outcome Measures

Name	Time	Method
The Musculoskeletal Tumor Society (MSTS) score	up to 24 months postoperatively	The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Harris Hip Score	up to 24 months postoperatively	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.
Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.	up to 24 months postoperatively	The adverse event form records the occurence of implant-related complications that occur during study participation.

Secondary Outcome Measures

Name	Time	Method
Gait Analysis as reported on the study's case report form	up to 24 months postoperatively	Motion data collected from gait analysis testing will be evaluated with OpenCap.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States