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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: February 1, 2017
Last verified: February 2017
  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 Donnis Rafferty, 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 ]
    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 ]

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)
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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. 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.

  Contacts and Locations
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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: February 1, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on May 25, 2017