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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

July 19, 2011
September 25, 2015
July 2011
December 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01398800 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty
Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty
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
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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample
All patients of Colorado Joint Replacement
Arthroplasty, Replacement, Knee
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Requiring a revision of a primary knee replacement
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01398800
IIS-000113
No
Not Provided
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Donnis Rafferty, Colorado Joint Replacement
Colorado Joint Replacement
DePuy Orthopaedics
Principal Investigator: Raymond Kim, MD Colorado Joint Replacement
Colorado Joint Replacement
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP