Primary Total Hip Arthroplasty
Conditions
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.
Interventions
OTHERCollarless 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.
OTHERCollared 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.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation | 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. |
Countries
United States
Contacts
Primary ContactMiles Hollimon, B.S.
Outcome results
None listed