Recruiting

Collared vs. Collarless

Sponsor:

Medstar Health Research Institute

Code:

NCT07337642

Conditions

Primary Total Hip Arthroplasty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Collarless Femoral Stem

Collared Femoral Stem

Study Details

Brief 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.

Conditions

Primary Total Hip Arthroplasty

Study ID

NCT07337642

Start date

Dec 3, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Collard stem

active comparator: Collarless stem

Interventions

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.

Primary outcome measure

  • Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation [ Time Frame: 6 weeks, 6 months, and 1 year post operation ]

Central Contacts and Locations

Central contacts

Miles Hollimon, B.S.

(202) 444-8766miles.hollimon@medstar.net

Locations

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Miles Hollimon, B.S.

(202) 444-8766miles.hollimon@medstar.net

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2026-01-13.