Status:
TERMINATED
3DKnee™ System vs. the MJS Knee System
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Rheumatoid Arthritis
Traumatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 alrea...
Detailed Description
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 alrea...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00764803
Start Date
January 1 2008
End Date
December 1 2009
Last Update
March 11 2010
Active Locations (1)
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1
Center for Excellence
Fresno, California, United States, 93710