3DKnee™ System vs. the MJS Knee System

March 9, 2010 updated by: Encore Medical, L.P.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93710
        • Center for Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encore Medical, L.P.

Investigators

  • Principal Investigator: D. Kevin Lester, M.D., Center for Excellence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS - 702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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