NCT00965146

Scorpio® Cruciate Retaining (CR) Outcomes Study

An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arthropathy of Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-06-01
• Primary completion: 2009-07-23
• First posted: 2009-08-25
• Last updated: 2017-11-17
• Results posted: 2013-02-15

Locations

5 sites across 1 country: United States