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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03261544
Status
Recruiting
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Conditions

  • Bone Metastases
  • Proximal Femur Replacement
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Proximal Femur Replacement — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Nov 10, 2017
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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 Measure

The Musculoskeletal Tumor Society (MSTS) score [ Time Frame: up to 24 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
Elizabeth Sachs

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