Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing

This study has been completed.
Sponsor:
Collaborator:
Corin
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01353326
First received: September 30, 2009
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.


Condition Intervention
Osteoarthritis
Device: Cormet
Device: Conserve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Cemented Versus Cementless Femoral Component for Metal on Metal Hip Resurfacing Assessing Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Percent change in BMD [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implant Migration [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Patient functionality [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: May 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cementless Hip Resurfacing Device: Cormet
Cementless hip resurfacing system
Other Names:
  • Cormet Hip Resurfacing System
  • Corin
Active Comparator: Cemented Hip Resurfacing Device: Conserve
Cemented hip resurfacing system
Other Names:
  • Conserve Plus Total Resurfacing Hip System
  • Wright

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease
  • must be skeletally mature, as determined by Risser sign or reaching 18 years of age
  • Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years

Exclusion Criteria:

  • Previous fusions, acute femoral neck fractures, and above knee amputations
  • evidence of active local infection
  • neurologic or musculoskeletal disease that may adversely affect gait or weight bearing
  • having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
  • BMI >35
  • neuropathic joints
  • severe documented psychiatric disease
  • patients requiring structural bone grafts
  • documented allergy to cobalt chromium molybdenum
  • ipsilateral girdlestone
  • sickle cell disease
  • significant femoral head or neck deformity, or significant acetabular wall deficiency
  • patients with renal failure, defined as serum creatinine greater that 180 µmol/L
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353326

Locations
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Corin
Investigators
Principal Investigator: Dr. Paul Beaule OHRI
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01353326     History of Changes
Other Study ID Numbers: 2008058-01H
Study First Received: September 30, 2009
Last Updated: January 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
non-inflammatory degenerative joint disease
hip resurfacing
bone mineral density
cemented
cementless

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014