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

This study is currently recruiting participants.
Verified June 2013 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Dr. P. Beaule, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01558752
First received: March 16, 2012
Last updated: June 7, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 1 Year Post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Osteoclast Activity (N-telopeptides of Type-I collagen) [ Time Frame: 1 Year post-operative ] [ Designated as safety issue: No ]
  • Implant migration [ Time Frame: 2 years post-operative ] [ Designated as safety issue: No ]
    Stem and cup migration measured using EBRA-FCA software

  • Harris Hip Score [ Time Frame: 2 Years post-operative ] [ Designated as safety issue: No ]
  • RAND-36 Questionnaire [ Time Frame: 2 Years post-operative ] [ Designated as safety issue: No ]
  • WOMAC Questionnaire [ Time Frame: 2 Years post-operative ] [ Designated as safety issue: No ]
  • UCLA Activity Scale [ Time Frame: 2 Years post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558752

Contacts
Contact: Jae-Jin Ryu, Ph.D 613-737-8920 jaryu@ohri.ca
Contact: Sandra Gordon, RN 613-737-8920 sgordon@ohri.ca

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

No publications provided

Responsible Party: Dr. P. Beaule, Head, Adult Reconstruction, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01558752     History of Changes
Other Study ID Numbers: 2010913-01H
Study First Received: March 16, 2012
Last Updated: June 7, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 18, 2013