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Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty (MBT)

This study is currently recruiting participants.
Verified July 2011 by Colorado Joint Replacement
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by:
Colorado Joint Replacement
ClinicalTrials.gov Identifier:
NCT01398800
First received: July 19, 2011
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design


Condition
Arthroplasty, Replacement, Knee

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Colorado Joint Replacement:

Primary Outcome Measures:
  • Function and knee score of the knee society scoring at every 2 years until 10 years. [ Time Frame: 1-10 years post operative of revision ] [ Designated as safety issue: No ]
    Follow up data of 1,2,4,6,8,and 10 years to evaluate bearing complications and clinical results for the use of MB in revision TKA. Retrospective clinical and radiographic evaluation of 197 mobile bearing revision TKA's will be collected. We will also analyze patient demographics and reason for revisions as well as implants used in revision.


Secondary Outcome Measures:
  • Radiographic analysis by our orthopedic clinician to determine component failure or loosening. [ Time Frame: Post op - 1-10 years or revision surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients of Colorado Joint Replacement

Criteria

Inclusion Criteria:

  • Requiring a revision of a primary knee replacement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398800

Locations
United States, Colorado
Colorado Joint Replacement Recruiting
Denver, Colorado, United States, 80210
Contact: Jane A Mang, RN     303-260-2905        
Principal Investigator: Ray Kim, MD            
Sponsors and Collaborators
Colorado Joint Replacement
DePuy Orthopaedics
Investigators
Principal Investigator: Raymond Kim, MD Colorado Joint Replacement
  More Information

No publications provided

Responsible Party: Dr. Raymond Kim, Colorado Joint Replacement
ClinicalTrials.gov Identifier: NCT01398800     History of Changes
Other Study ID Numbers: IIS-000113
Study First Received: July 19, 2011
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013