Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMedstar Health Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Collarless Femoral Stem

    Other intervention

    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

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Collard stemActive comparator 1 intervention
Group B: Collarless stemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks, 6 months, and 1 year post operation

Secondary outcomes

Other outcomes

Sponsors and contacts

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