NCT01418378

Sigma CR150 Versus Sigma CR Knee RCT

A Double-blinded Randomised Controlled Trial Comparing the Performance of the Sigma® CR150 and Sigma® CR Knee Systems, When Used in Fixed Bearing Primary Cruciate Retaining Total Knee Arthroplasty for the Treatment of Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will compare two very similar designs of knee replacement device. One device (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified to enhance/accommodate higher flexion. The original device has been in widespread clinical use with excellent results since 1996 and this study will determine whether the design modifications of the newer device add further value. The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009. Achieving higher knee flexion may be required for cultural reasons or by the increasingly younger, more active patient population undergoing knee replacement today. In addition to promoting flexion, it is also possible that this design change may help the knee replacement to last longer than traditional implants in patients who achieve higher flexion. Therefore, the study will compare the two devices in terms of survivorship, flexion and other measures of the success of a total knee replacement (range of motion, knee-related quality of life, activity and generic quality of life) over the short-term. A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and aged 50-75 years will be included at UK/international hospitals. Study duration is 2 years and patients will complete standard knee outcome scores plus radiological evaluation. Subjects would receive one of the study devices regardless of their involvement in the study, and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and follow-up care will be as per the care they would receive outside of the study.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Sigma CR150	Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
DEVICE	Sigma CR	Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).

Timeline

• Start date: 2011-08-03
• Primary completion: 2016-02-17
• Completion: 2016-02-17
• First posted: 2011-08-17
• Last updated: 2019-08-28
• Results posted: 2019-05-31

Locations

4 sites across 3 countries: India, Singapore, United Kingdom