Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03261544

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Duke University · Academic / Other
Sex
All
Age
16 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREProximal Femur ReplacementThe 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.

Timeline

Start date
2017-11-10
Primary completion
2027-06-01
Completion
2028-11-01
First posted
2017-08-25
Last updated
2025-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03261544. Inclusion in this directory is not an endorsement.