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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261544
• Other study ID #: Pro00082717
• Status: Recruiting
• Start date: November 10, 2017
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: Elizabeth Sachs, MS
• Phone: 9196609849
• Email: elizabeth.sachs[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Proximal Femur Replacement
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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