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Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty (MBT)
| Tracking Information | ||||
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| First Received Date ICMJE | July 19, 2011 | |||
| Last Updated Date | February 1, 2017 | |||
| Start Date ICMJE | July 2011 | |||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01398800 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Radiographic analysis by our orthopedic clinician to determine component failure or loosening. [ Time Frame: Post op - 1-10 years or revision surgery ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty | |||
| Official Title ICMJE | Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty | |||
| 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. |
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| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | All patients of Colorado Joint Replacement | |||
| Condition ICMJE | Arthroplasty, Replacement, Knee | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Active, not recruiting | |||
| Estimated Enrollment ICMJE | 320 | |||
| Estimated Completion Date | December 2018 | |||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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. |
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| Sex/Gender |
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| Ages | Child, Adult, Senior | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01398800 | |||
| Other Study ID Numbers ICMJE | IIS-000113 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Undecided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Donnis Rafferty, Colorado Joint Replacement | |||
| Study Sponsor ICMJE | Colorado Joint Replacement | |||
| Collaborators ICMJE | DePuy Orthopaedics | |||
| Investigators ICMJE |
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| PRS Account | Colorado Joint Replacement | |||
| Verification Date | February 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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