Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

MedStar Health

Status

Enrolling

Conditions

Primary Total Hip Arthroplasty

Treatments

Other: Collared Femoral Stem

Other: Collarless Femoral Stem

Study type

Interventional

Funder types

Other

Identifiers

NCT07337642

STUDY00009612

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.