Text Size

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

This study is currently recruiting participants.
Verified December 2011 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Corin
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01353326
First received: September 30, 2009
Last updated: July 11, 2012
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

Contacts
Contact: Kyle Kemp, MSc 613-737-8899 ext 78920 kykemp@toh.on.ca

Locations
Canada, Ontario
Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Kyle Kemp, MSc     613-737-8899 ext 78920        
Principal Investigator: Dr. Paul Beaule            
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: July 11, 2012
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 May 22, 2013