Scorpio® Cruciate Retaining (CR) Outcomes Study

Status Terminated

Clinical Trial Summary

The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00965146
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Terminated
Phase	N/A
Start date	June 2001

View Details

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