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