MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
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.
Time frame: 24 months
Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
Assessment of migration in each individual plane (x, y, and z), as measured in mm.
Time frame: 24 months
Assess if migration pattern is greater than 0.2mm between 1 and 2 years
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.
Time frame: 24 months
Patient functional outcomes (HOOS)
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.
Time frame: 24 months
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