3DKnee™ System vs. the MJS Knee System

Rheumatoid Arthritis Clinical Trial

Official title:

Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764803
• Other study ID #: PS - 702
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: March 9, 2010
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Joint Disease Secondary to Osteoarthritis
• Joint Diseases
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• Encore 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.
• Encore 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.

Locations

Country	Name	City	State
United States	Center for Excellence	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System		2 year	No

External Links

•   Sponsor company home page