Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collarless Femoral Stem, Collared Femoral Stem.
- Who it may be relevant to
- Registry conditions: Primary Total Hip Arthroplasty. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty
Overview
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
- 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 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.
Primary outcome measures
- Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation [Time frame: 6 weeks, 6 months, and 1 year post operation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- MedStar Georgetown University Hospital — Washington D.C.
Identifiers
NCT: NCT07337642 · STUDY00009612