Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Medstar Health Research Institute
- Study ID
- NCT07337642
- Status
- Recruiting
Conditions
- Primary Total Hip Arthroplasty
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Collarless Femoral Stem — OTHERPatients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collarless femoral stem implant at time of surgery.
- Collared Femoral Stem — OTHERPatients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collared femoral stem at the time of surgery.
Study Details
This is a prospective randomized control trial comparing two collared and collarless femoral implants used in primary total hip arthroplasty. The specific aims of this trial are to: SA1: Prospectively assess clinical outcomes in patients undergoing primary total hip arthroplasty with a collared versus collarless femoral stem of the same design. SA2: Evaluate serial radiographs to quantify differences in subsidence between collared and collarless implant groups. SA3: Report and compare incidence rates of intraoperative and postoperative periprosthetic fractures and aseptic loosening following primary total hip arthroplasty with use of either a collared or collarless stem. Hypothesis: The addition of a collar to the same designed triple-taper primary hip stem will lead to a reduction in subsidence and incidence of perioperative and periprosthetic femur fractures.
Key Dates
- Start date
- Dec 3, 2025
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Collard stem
- Active Comparator: Collarless stem
Primary Outcome Measure
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation [ Time Frame: 6 weeks, 6 months, and 1 year post operation ]
Central Contacts
- Miles Hollimon, B.S.(202) 444-8766
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 |