Trials / Recruiting
RecruitingNCT07337642
Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty
Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Medstar Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Collarless Femoral Stem | Patients 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. |
| OTHER | Collared Femoral Stem | Patients 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. |
Timeline
- Start date
- 2025-12-03
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2026-01-13
- Last updated
- 2026-01-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07337642. Inclusion in this directory is not an endorsement.