Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-75
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Proximal Femur Replacement
Procedure/SurgeryThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Proximal Femur Replacement1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 24 months postoperatively2
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.
Time frame
up to 24 months postoperatively3
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.
Time frame
up to 24 months postoperativelySecondary outcomes
1
Gait Analysis as reported on the study's case report form
Motion data collected from gait analysis testing will be evaluated with OpenCap.
Time frame
up to 24 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov