The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use. The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions. Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation. The objectives of this study are to: 1. Evaluate the effect of system component design on functional performance. 2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative. 3. Evaluate complications and the rates in which they occur.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
215
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, United States
Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, United States
Jewish Physician Group
Louisville, Kentucky, United States
Dearborn Orthopaedics
Dearborn, Michigan, United States
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Time frame: 15 years
Evaluate Complication Rate.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Time frame: 15 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beth Israel Medical Center
New York, New York, United States