Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components (TOPAZ)
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|ClinicalTrials.gov Identifier: NCT02668211|
Recruitment Status : Withdrawn (Not feasible - RSA machine not available. RSA images needed for study endpoints)
First Posted : January 29, 2016
Last Update Posted : December 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Joint Disease Osteoarthritis||Device: PROFEMUR Preserve Classic Femoral Components||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
PROFEMUR Preserve RSA
Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components
Device: PROFEMUR Preserve Classic Femoral Components
Other Name: Total Hip Arthroplasty System
- Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance. [ Time Frame: 24 months ]Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.
- Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA [ Time Frame: 24 months ]Assessment of migration in each individual plane (x, y, and z), as measured in mm.
- Assess if migration pattern is greater than 0.2mm between 1 and 2 years [ Time Frame: 24 months ]To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.
- Patient functional outcomes (HOOS) [ Time Frame: 24 months ]The secondary objective is to determine if there is a significant difference in health status and functional outcomes (using the HOOS questionnaire) before and after total hip arthroplasty (THA) using the PROFEMUR® Preserve Femoral Components.
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): NCT02668211
|Hopital Maisonneuve Rosemont|
|Montreal, Quebec, Canada, H1T 2M4|