About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥ 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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Collarless Femoral Stem
Other interventionPatients 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
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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