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Clinical Trials/NCT01398800
NCT01398800
Completed
Not Applicable

Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Colorado Joint Replacement1 site in 1 country340 target enrollmentStarted: July 2011Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
340
Locations
1
Primary Endpoint
Function and knee score of the knee society scoring at every 2 years until 10 years.

Overview

Brief Summary

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

Detailed Description

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.

Exclusion Criteria

  • None since they have all required a revision.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Radiographic analysis by our orthopedic clinician to determine component failure or loosening.(Post op - 1-10 years or revision surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donnis Rafferty

Dr. Raymond Kim

Colorado Joint Replacement

Study Sites (1)

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