Bone Metastases, Proximal Femur Replacement, Sarcoma
Conditions
Brief 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.
Interventions
PROCEDUREProximal 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.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Musculoskeletal Tumor Society (MSTS) score | up to 24 months postoperatively | The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function. |
| Harris Hip Score | up to 24 months postoperatively | 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. |
| Number of patients with an implant-related complication as reported on the adverse event form upon participation completion. | up to 24 months postoperatively | The adverse event form records the occurence of implant-related complications that occur during study participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Analysis as reported on the study's case report form | up to 24 months postoperatively | Motion data collected from gait analysis testing will be evaluated with OpenCap. |
Countries
United States
Contacts
CONTACTElizabeth Sachs, MS
PRINCIPAL_INVESTIGATORWilliam Eward, MD, DVM
Duke University
Outcome results
None listed