Joint Disease Secondary to Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
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 already under way.
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 already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.
Interventions
DEVICEEncore 3DKnee™ system
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.
DEVICEEncore MJS™ Knee System
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.
Sponsors
Encore Medical, L.P.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System | 2 year |
Countries
United States
Outcome results
None listed