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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Cormet Device: Conserve||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
Cementless hip resurfacing system
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.
Cemented hip resurfacing system
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1H8L6|
|Principal Investigator:||Dr. Paul Beaule, MD, FRCSC||Ottawa Hospital Research Institute|