3DKnee™ System vs. the MJS Knee System

This study has been terminated.
(Corporate decision to discontinue distribution of MJS Knee.)
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764803
First received: September 30, 2008
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Traumatic Arthritis
Joint Disease Secondary to Osteoarthritis
Device: Encore 3DKnee™ system
Device: Encore MJS™ Knee System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764803

Locations
United States, California
Center for Excellence
Fresno, California, United States, 93710
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: D. Kevin Lester, M.D. Center for Excellence
  More Information

Additional Information:
No publications provided

Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764803     History of Changes
Other Study ID Numbers: PS - 702
Study First Received: September 30, 2008
Last Updated: March 9, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014