Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

Purpose

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.

Condition

  • Primary Total Hip Arthroplasty

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Collard stem
  • Other: 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.
    Other names:
    • collared
Active Comparator
Collarless stem
  • Other: 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.
    Other names:
    • Collarless

Recruiting Locations

MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Miles Hollimon, B.S.
(202) 444-8766
miles.hollimon@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Miles Hollimon, B.S.
(202) 444-8766
miles.hollimon@medstar.net