A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the two year post-operative interval, as measured radiographically in zones 1 and 7. 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. Bilateral DXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 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. The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the SF-36 Item Health Survey, WOMAC and UCLA activity scale.

Official Title
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A Randomized Clinical Trial of a Modular Cementless Acetabular Metal on Poly Component Versus a Monoblock Cementless Titanium Shell With Ceramic on Ceramic Bearing and CORAIL Stem: A Bone Mineral Density Study

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Device: Total hip replacement with titanium shell and CORAIL stem
* Device: Total hip replacement with Modular Titanium Femoral Stem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titanium Shell with CORAIL stem<br>Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. | Device: Total hip replacement with titanium shell and CORAIL stem<br>* Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).<br>|
| Active Comparator: Modular Titanium Femoral Stem (Tri-Lock)<br>Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). | Device: Total hip replacement with Modular Titanium Femoral Stem<br>* Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Mineral Density | To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease. | 2 Years Post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Bone Turnover Markers Between Groups | Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative. | 2 Years post-operative | 
| Implant Migration | Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative. | 2 years post-operative | 
| Change in Modified Harris Hip Score | The change from baseline to 2-years post-operative on the Modified Harris Hip Score (mHHS). The mHHS assesses a patient's functional outcome and pain. The maximum score is 100 and the lowest is 0. A higher score is indicative of better outcomes and lower pain levels. | 2 Years post-operative | 
| Change in SF-36 Score | The change from baseline to 2-years post-operative on the SF-36 score: a quality of-life measure. The score consists of 36 questions separated into 8 concepts. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100. The health related quality of life is increases as the scores are increased. The average score is 50. | 2 Years post-operative | 
| Change in WOMAC Questionnaire | The change from baseline to 2-years post-operative on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score consists of 24 items, separated into 3 subscales. Each question is scored on a scale of 0 to 4, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The scores of each subscale are summed to give a total score. Higher scores are indicative of worse pain, stiffness and functional limitations. | 2 Years post-operative | 
| Change in UCLA Activity Scale | The change from baseline to 2-years post-operative on the UCLA Activity score. The UCLA activity scale is a 10 point scale evaluating a patients activity level. The possible score range is from 0-10. A low value is indicative of sedentary or inactivity, whereas a high score is indicative of high levels of activity. | 2 Years post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DXA-RFA, Total Hip Replacement, Bone Mineral Density, Stem, Dual-energy x-ray absorptiometry, Corail, Tri-Lock