Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip joint.
Study Type
OBSERVATIONAL
Enrollment
25
PROFEMUR PRESERVE total hip arthroplasty femoral stem
Spokane Joint Replacement Center
Spokane, Washington, United States
Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
Time frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
Hip functional outcomes will be assessed using the Harris Hip score.
Time frame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem.
Time frame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Implant survivorship of the femoral stem will be calculated.
Time frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
Rate of complications will be assessed.
Time frame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Hip functional outcomes will be assessed using the Forgotten Joint Score.
Time frame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
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