Evaluating the best methods for reattaching hip muscles after femur replacement
Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
This study is testing different ways to reattach hip muscles after femur replacement surgery to see if one method helps patients recover better than others.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03261544 on ClinicalTrials.gov |
What this trial studies
This study assesses the functional outcomes of patients who have undergone proximal femur resection and reconstruction using an endoprosthesis, focusing on different techniques for reattaching the abductor muscles. The hypothesis is that patients whose abductors are directly reattached to the prosthesis will experience improved functional outcomes. The study will utilize the Duke DEDUCE database to identify eligible patients and will involve a review of up to 300 medical charts, ultimately consenting 50 subjects for the study. The goal is to develop a simple and cost-effective method for assessing abductor function through plain radiographs during post-operative visits.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone or are scheduled for proximal femur replacement by an orthopedic oncology surgeon.
Not a fit: Patients who are non-ambulatory before or after the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved functional recovery for patients undergoing proximal femur replacement.
How similar studies have performed: While similar studies have explored functional outcomes in orthopedic surgeries, this specific approach to abductor reattachment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: William Eward, MD, DVM — Duke University
- Study coordinator: Elizabeth Sachs, MS
- Email: elizabeth.sachs@duke.edu
- Phone: 9196609849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.