RecruitingNot ApplicableNCT07337642

Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty


Sponsor

Medstar Health Research Institute

Enrollment

100 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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

Exclusion Criteria7

  • 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 ≤ -2.5) or known metabolic bone disease.
  • Inability to complete follow-up or anticipated relocation out of the area.

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Interventions

OTHERCollarless 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.

OTHERCollared 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.


Locations(1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

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NCT07337642


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