Study Stopped
Corporate decision to discontinue distribution of MJS Knee.
3DKnee™ System vs. the MJS Knee System
Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
1 other identifier
observational
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 11, 2010
March 1, 2010
1.8 years
September 30, 2008
March 9, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
2 year
Study Arms (2)
2
Subjects who meet the indications for use and are implanted with the Encore MJS™ Knee System.
1
Subjects who meet the indications for and are implanted with the Encore 3DKnee™ system.
Interventions
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.
Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.
Eligibility Criteria
Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Excellence
Fresno, California, 93710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
D. Kevin Lester, M.D.
Center for Excellence
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
January 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
March 11, 2010
Record last verified: 2010-03