Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty
NCT ID: NCT07337642
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-03
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Collard stem
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.
Collarless stem
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary osteoarthritis or other non-inflammatory degenerative joint disease.
* Ability and willingness to comply with study procedures and follow-up schedule.
* Ability to provide written informed consent
Exclusion Criteria
* Prior surgery on the ipsilateral hip (e.g., prior THA, internal fixation, osteotomy)
* Use of cemented or hybrid femoral components.
* Revision THA or conversion THA
* Active or prior infection of the hip joint.
* Severe osteoporosis (T-score ≤ -2.5) or known metabolic bone disease.
* Inability to complete follow-up or anticipated relocation out of the area.
18 Years
99 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Locations
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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STUDY00009612
Identifier Type: -
Identifier Source: org_study_id
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