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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
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Donnis Rafferty, Colorado Joint Replacement

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

Condition or disease
Arthroplasty, Replacement, Knee

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 Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. 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 :
  1. Radiographic analysis by our orthopedic clinician to determine component failure or loosening. [ Time Frame: Post op - 1-10 years or revision surgery ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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.


Information from the National Library of Medicine

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


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

Responsible Party: Donnis Rafferty, Dr. Raymond Kim, Colorado Joint Replacement
ClinicalTrials.gov Identifier: NCT01398800     History of Changes
Other Study ID Numbers: IIS-000113
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided