Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty (MBT)
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|ClinicalTrials.gov Identifier: NCT01398800|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2011
Last Update Posted : February 2, 2017
|Condition or disease|
|Arthroplasty, Replacement, Knee|
Failure modes of revision total knee arthroplasty (TKA) that include prosthetic loosening and damage to constraining mechanisms often require revision TKA. Mobile bearing revision TKA components have been developed in hopes of lessening these failure mechanisms. Our purpose is to evaluate the use of mobile bearings in revision TKA.
Retrospective clinical and radiographic evaluation of 340 revision mobile bearing TKAs using the PFC Sigma and LCS posterior stabilized rotating platform implants (Depuy, Warsaw, IN) will be performed. Indications for revision include instability, loosening, arthrofibrosis, chronic hemarthrosis, failed patellofemoral replacement, failed unicompartmental knee replacement, infection reimplantation, and supracondylar fracture nonunion.
|Study Type :||Observational|
|Estimated Enrollment :||320 participants|
|Official Title:||Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- 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 ]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.
- Radiographic analysis by our orthopedic clinician to determine component failure or loosening. [ Time Frame: Post op - 1-10 years or revision surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398800
|United States, Colorado|
|Colorado Joint Replacement|
|Denver, Colorado, United States, 80210|
|Principal Investigator:||Raymond Kim, MD||Colorado Joint Replacement|