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

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ClinicalTrials.gov Identifier: NCT01558752
Recruitment Status : Recruiting
First Posted : March 20, 2012
Last Update Posted : August 8, 2016
Johnson & Johnson
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

The main goal 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 one 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 DEXA 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 RAND-36 Item Health Survey, WOMAC and UCLA activity scale.

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Device: Total hip replacement with titanium shell and CORAIL stem Device: Total hip replacement with Modular Titanium Femoral Stem (Tri-lock) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Titanium Shell with CORAIL stem Device: Total hip replacement with titanium shell and CORAIL stem
Total hip replacement with titanium shell and CORAIL stem
Active Comparator: Modular Titanium Femoral Stem (Tri-Lock) Device: Total hip replacement with Modular Titanium Femoral Stem (Tri-lock)
Total hip replacement with modular titanium femoral stem (Tri-lock)

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 1 Year Post-operative ]

Secondary Outcome Measures :
  1. Osteoclast Activity (N-telopeptides of Type-I collagen) [ Time Frame: 1 Year post-operative ]
  2. Implant migration [ Time Frame: 2 years post-operative ]
    Stem and cup migration measured using EBRA-FCA software

  3. Harris Hip Score [ Time Frame: 2 Years post-operative ]
  4. RAND-36 Questionnaire [ Time Frame: 2 Years post-operative ]
  5. WOMAC Questionnaire [ Time Frame: 2 Years post-operative ]
  6. UCLA Activity Scale [ Time Frame: 2 Years post-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558752

Contact: Jae-Jin Ryu, Ph.D 613-737-8920 jaryu@ohri.ca
Contact: Peter Breithaup, MSc 613-737-8920 pbreithaup@ohri.ca

Canada, Ontario
The Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Johnson & Johnson
Principal Investigator: Paul E Beaulé, MD, FRCSC Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01558752     History of Changes
Other Study ID Numbers: 2010913-01H
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Ottawa Hospital Research Institute:
Total hip replacement
Bone mineral density (BMD)