Actively Recruiting

Age: 16Years - 75Years
All Genders
ID03261544

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

Led by Duke University · Updated on 2025-08-22

50

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to evaluate how different methods of reattaching the abductor muscles during proximal femur resection and reconstruction with an endoprosthesis affect patient function. The study focuses on patients treated at Duke University Medical Center by orthopedic oncology surgeons for conditions such as sarcoma and bone metastases. Researchers want to find out if directly attaching the abductors to the prosthesis leads to better functional outcomes and develop a simple way to assess this function using routine X-rays during follow-up visits. The study involves reviewing up to 300 patient records retrospectively to identify those who had a proximal femur replacement. From these, 50 patients will be consented: 25 who have upcoming clinic visits and 25 who are scheduled for surgery. The intervention under observation is the proximal femur replacement procedure with different abductor muscle repair techniques. There is no drug or placebo; instead, the focus is on surgical methods and outcomes after the procedure. Participants will be followed for up to 24 months after surgery to assess their recovery and function. This includes measuring function with the Musculoskeletal Tumor Society score and Harris Hip Score, tracking any implant-related complications, and performing gait analysis. Clinical visits will include plain radiographs to evaluate abductor muscle function. The study also monitors safety and adverse events during this period, providing a comprehensive view of patient outcomes after their proximal femur replacement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to a few weeks following surgery

Participants undergo proximal femur replacement surgery and receive immediate post-operative care.

Post-operative Follow-up

Duration - Up to 24 months postoperatively

Participants are followed for functional outcomes and implant-related complications after surgery.

Scheduled follow-up visits over 24 months

Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

E

Elizabeth Sachs, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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