N/A
Completed N=88
A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study
Source: ClinicalTrials.gov NCT01558752 ↗Enrolled (actual)
88
Serious AEs
2.3%
Results posted
Dec 2020
Primary outcomePrimary: Change in Bone Mineral Density — 1072; 1295 number of pixels with change
Summary
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density |
1072; 1295 | — |
| SECONDARY Comparison of Bone Turnover Markers Between Groups |
— | — |
| SECONDARY Implant Migration |
— | — |
| SECONDARY Change in Modified Harris Hip Score |
— | — |
| SECONDARY Change in SF-36 Score |
— | — |
| SECONDARY Change in WOMAC Questionnaire |
— | — |
| SECONDARY Change in UCLA Activity Scale |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are undergoing primary hip surgery for osteo/degenerative arthritis (does not include traumatic arthritis, congenital hip dysplasia, or avascular necrosis).
- Patients who are skeletally mature, as determined by Risser sign or at least 18 years of age
- Patients under 75 years of age
- Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period.
Exclusion Criteria
- Patients with previous fusions, acute femoral neck fractures and above knee amputations.
- Patients with evidence of active local infection
- Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
- Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device, or any prior hip surgery or retained internal fixation.
- Patients who are anticipated to require contralateral hip surgery in the next year
- Patients with known disorders of bone metabolism, systemic inflammatory disorders, and use of drug medications, including oral steroids, HRT, Tamoxifen, calcium, or vitamin D in the past year, and any past bisphosphonate therapy.
- Patients with a Body Mass Index (BMI) > 35
- Patients with neuropathic joints
- Patients with severe documented psychiatric disease
- Patients requiring structural bone grafts
- Patients with an ipsilateral girdlestone
- Patients with sickle cell disease
- Patients with major acetabular bone stock deficiency
Data sourced from ClinicalTrials.gov (NCT01558752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.