Scorpio® Cruciate Retaining (CR) Outcomes Study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System|
- Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings. [ Time Frame: 15 years ] [ Designated as safety issue: No ]This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
- Evaluate Complication Rate. [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
|Study Start Date:||June 2001|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Experimental: Scorpio® CR Total Knee System
Scorpio® CR Total Knee System Study Device
Device: Scorpio® CR Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
Other Name: 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:
- Evaluate the effect of system component design on functional performance.
- Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
- Evaluate complications and the rates in which they occur.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965146
|United States, Arkansas|
|Foundation for Musculoskeletal Research and Education|
|Little Rock, Arkansas, United States, 72205|
|United States, Indiana|
|Orthopaedic Research Foundation, Inc.|
|Indianapolis, Indiana, United States, 46237|
|United States, Kentucky|
|Jewish Physician Group|
|Louisville, Kentucky, United States, 40202|
|United States, Michigan|
|Dearborn, Michigan, United States, 48124|
|United States, New York|
|Beth Israel Medical Center|
|New York, New York, United States, 10021|
|Study Chair:||C. Lowry Barnes, MD||Foundation for Musculoskeletal Research and Education|
|Principal Investigator:||Lawrence Morawa, MD||Dearborn Orthopaedics|
|Principal Investigator:||Arthur Malkani, MD||Jewish Physician Group|
|Principal Investigator:||Frank Kolisek, MD||Orthopaedic Research Foundation, Inc.|
|Principal Investigator:||Steven Harwin, MD||Beth Israel Medical Center|