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

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ClinicalTrials.gov Identifier: NCT01353326
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
Corin
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Cormet Device: Conserve Not Applicable

Detailed Description:
Recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. Certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. More specifically, we are trying to compare outcomes between patients who receive the cementless Cormet Hip Resurfacing System to those who receive the cemented CONSERVE® Plus Total Resurfacing Hip System. Therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. We are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Actual Study Start Date : May 15, 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cementless Hip Resurfacing
Patients randomized into the Cementless Hip Resurfacing Group will have their hip resurfaced with the cementless Cormet / Corin Hip Resurfacing System.
Device: Cormet
Cementless hip resurfacing system
Other Names:
  • Cormet Hip Resurfacing System
  • Corin
Active Comparator: Cemented Hip Resurfacing
Patients randomized into the Cemented Hip Resurfacing Group will have their hip resurfaced with the cemented Conserve Plus Total Resurfacing Hip System.
Device: Conserve
Cemented hip resurfacing system
Other Names:
  • Conserve Plus Total Resurfacing Hip System
  • Wright



Primary Outcome Measures :
  1. Percent change in BMD (g/cm2) [ Time Frame: 12 months ]
    The primary outcome is percent change in BMD (g/cm2) from baseline to the 1-year post-operative interval, as measured radiographically in zone L1. Analysis of periprosthetic BMD will be achieved using 6 zones of the femoral neck, which have been used in previous studies


Secondary Outcome Measures :
  1. Implant Migration [ Time Frame: 24 months ]
    Radiographs will be taken preoperatively and until 24 months post-operatively to assess for any cup loosening. Implant migration, both vertical and horizontal, will be measured on serial radiographs using the computer-assisted Ein Bild Röentgen Analyse (EBRA) software for cup migration.

  2. Harris Hip Score (HHS) Questionnaire [ Time Frame: 24 months ]
    The Harris Hip Score (HHS) is intended to evaluate various hip disabilities and methods of treatment. The HHS is comprised of 4 domains: pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The total score is calculated by summing the scores for the 4 domains. The higher the HHS, the less dysfunction.

  3. WOMAC Questionnaire to assess functionality [ Time Frame: 24 months ]
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), and function (17 items). This questionnaire is self-administered using the 5-point Likert-type scale (none, mild, moderate, severe, extreme). These correspond to an ordinal scale of 0-4. The scores are summed (0-100), where higher scores are indicative of worse pain, stiffness, and functional limitations.

  4. RAND-36 Item Health Survey [ Time Frame: 24 months ]
    The RAND-36 Item Health Survey assesses patient health-related quality of life and consists of 8 health concepts: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (3 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range, with a high score defined as a more favourable health state. Scores are averaged together to create the 8 scale scores.

  5. UCLA Activity Score [ Time Frame: 24 months ]
    The UCLA Activity Score will be used to assess the patients highest-rated activity, regardless of the frequency or intensity of participation. Patients are asked to select 1 out of 10 possible answers that best fit their current activity level (0-10). Low values are indicative of a sedentary lifestyle, while higher values are indicative of high impact activities.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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, MD, FRCSC Ottawa Hospital Research Institute

Publications of Results:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01353326     History of Changes
Other Study ID Numbers: 2008058-01H
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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