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

Not Applicable

Completed

Conditions: Total Hip Arthroplasty

Interventions: Device: Total hip replacement with titanium shell and CORAIL stem
Device: Total hip replacement with Modular Titanium Femoral Stem

Registration Number: NCT01558752

Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Titanium Shell with CORAIL stem	Total hip replacement with titanium shell and CORAIL stem	Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.
Modular Titanium Femoral Stem (Tri-Lock)	Total hip replacement with Modular Titanium Femoral Stem	Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).

Primary Outcome Measures

Name	Time	Method
Change in Bone Mineral Density	2 Years Post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Change in Modified Harris Hip Score	2 Years post-operative	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.
Comparison of Bone Turnover Markers Between Groups	2 Years post-operative	Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative.
Implant Migration	2 years post-operative	Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative.
Change in SF-36 Score	2 Years post-operative	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.
Change in WOMAC Questionnaire	2 Years post-operative	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.
Change in UCLA Activity Scale	2 Years post-operatively	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.