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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collard stem | Active Comparator |
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| Collarless stem | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collarless Femoral Stem | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation | Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation used radiographic evidence. | 6 weeks, 6 months, and 1 year post operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miles Hollimon, B.S. | Contact | (202) 444-8766 | miles.hollimon@medstar.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2025 | Jan 12, 2026 | Prot_000.pdf |
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| Collared Femoral Stem | Other | 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. |
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