- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398800
Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty (MBT)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80210
- Colorado Joint Replacement
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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1-10 years post operative of revision
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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Post op - 1-10 years or revision surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raymond Kim, MD, Colorado Joint Replacement
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IIS-000113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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