Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proximal Femur Replacement.
- Who it may be relevant to
- Registry conditions: Sarcoma, Bone Metastases, Proximal Femur Replacement. Basic parameters: 16 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- The Musculoskeletal Tumor Society (MSTS) score [Time frame: up to 24 months postoperatively]
- Harris Hip Score [Time frame: up to 24 months postoperatively]
- Number of patients with an implant-related complication as reported on the adverse event form upon participation completion. [Time frame: up to 24 months postoperatively]
Secondary outcome measures (1)
- Gait Analysis as reported on the study's case report form [Time frame: up to 24 months postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT03261544 · Pro00082717