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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Donnis Rafferty, Colorado Joint Replacement
ClinicalTrials.gov Identifier:
NCT01398800
First received: July 19, 2011
Last updated: September 25, 2015
Last verified: September 2015
  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:


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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398800

Locations
United States, Colorado
Colorado Joint Replacement
Denver, Colorado, United States, 80210
Sponsors and Collaborators
Colorado Joint Replacement
DePuy Orthopaedics
Investigators
Principal Investigator: Raymond Kim, MD Colorado Joint Replacement
  More Information

Responsible Party: Donnis Rafferty, 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: September 25, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 28, 2016