3DKnee™ System vs. the MJS Knee System

Stopped early

Conditions studied: Rheumatoid Arthritis, Traumatic Arthritis, Joint Disease Secondary to Osteoarthritis

In brief

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.

Key facts

Study ID

NCT00764803

Run by

Encore Medical, L.P.

People needed

27

Starts

2008-01-01

Expected to finish

2009-12-01

Last updated by the study team

2010-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• This must be a primary knee replacement on this knee.
• Patient is over 18 years of age or older
• Patients must have one of the following
• rheumatoid or traumatic arthritis OR
• joint disease secondary to osteoarthritis
• Patient is likely to be available for evaluation for the duration of the study
• Able and willing to sign the informed consent and follow study procedures
• Patient is not pregnant

You may not qualify if…

• Is younger than 18 years of age
• If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
• Overt infection
• Alcoholism or other addictions
• Muscular, neurological or vascular deficiencies which compromise the affected extremity
• Obesity
• Marked bone loss
• Materials sensitivity
• Prisoner
• Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
• Patient is pregnant

Where it is running

• Center for Excellence — Fresno, California, United States

Full record on ClinicalTrials.gov

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