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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Bone Metastases; Proximal Femur Replacement
• Intervention / Treatment: Procedure: Proximal Femur Replacement

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Elizabeth Sachs, MS; Phone Number: 9196609849; Email: elizabeth.sachs@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Elizabeth Sachs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Proximal Femur Replacement; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: William Eward, MD, DVM, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: Pro00082717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No