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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.