NCT00740376

Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System

A Prospective, Comparative, Randomized, Double Blind, Multi-center Study of the Uniglide™ Mobile Bearing Unicondylar Knee System vs. Uniglide™ Fixed Bearing Unicondylar Knee System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed Bearing Unicondylar Knee System (control device currently cleared) as measured by the Composite Clinical Success (CCS) endpoint.

Detailed description

Arthritic knees are the most common cause of long-term disability resulting in decreased mobility and increased pain. After other treatments for pain relief and return to activities of daily living fail, knee joint replacement is often the best option and unicompartmental knee arthroplasty was introduced as an appropriate treatment for management of osteoarthritis when disease effects only a portion of the knee joint. This study is a prospective, comparative, randomized, double blind (patient and post-operative evaluator), multi-center clinical study under a common protocol to determine the safety and effectiveness of the Uniglide Unicondylar Mobile Bearing knee implant system.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Uniglide Mobile Bearing Unicondylar Knee System	Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
DEVICE	Uniglide Fixed Bearing Unicondylar Knee System	Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2008-08-25
• Last updated: 2019-06-13
• Results posted: 2019-06-13

Locations

6 sites across 1 country: United States