Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

NCT07337642 | Recruiting FDA Device

• 1 other identifier: STUDY00009612
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  6 weeks, 6 months, and 1 year post operation

Study Arms (2)

Collard stem

ACTIVE COMPARATOR

Other: Collared Femoral Stem

Collarless stem

ACTIVE COMPARATOR

Other: Collarless Femoral Stem

Interventions

Collarless Femoral Stem OTHER

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.

Also known as: Collarless

Collarless stem

Collared Femoral Stem OTHER

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.

Also known as: collared

Collard stem

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Georgetown University Hospital

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

RECRUITING

Central Study Contacts

Miles Hollimon, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)