3DKnee™ System vs. the MJS Knee System

Terminated

• Conditions: Rheumatoid Arthritis; Traumatic Arthritis; Joint Disease Secondary to Osteoarthritis
• Interventions: Device: Encore MJS™ Knee System; Device: Encore 3DKnee™ system

• Registration Number: NCT00764803
• Lead Sponsor: Encore Medical, L.P.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-02
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-09
• Last Update Posted: 2010-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Encore MJS™ Knee System	Subjects who meet the indications for use and are implanted with the Encore MJS™ Knee System.
1	Encore 3DKnee™ system	Subjects who meet the indications for and are implanted with the Encore 3DKnee™ system.

Primary Outcome Measures

Name	Time	Method
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System	2 year

Trial Locations

Locations (1)

Center for Excellence; 🇺🇸 Fresno, California, United States