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โ† Trials
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Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

RecruitingNAAges 18 Years - 99 YearsAllMedstar Health Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults (โ‰ฅ 18 years old) scheduled for primary, uncemented THA using a cementless femoral stem * 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: * Patients not indicated for a cementless THA * 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 โ‰ค -2.5) or known metabolic bone disease. * Inability to complete follow-up or anticipated relocation out of the area.
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What it tests

  • Collarless Femoral Stem
  • Collared Femoral Stem
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Where

1 site
MedStar Georgetown University Hospital
Washington D.C., United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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