Microplasty Tibial Tray Data Collection (MTT)
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Microplasty Tibial Tray Multi-Center Data Collection|
- Knee Society Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Radiographic Data [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||June 2023|
|Estimated Primary Completion Date:||December 2022 (Final data collection date for primary outcome measure)|
510(k) Inclusion Criteria
Any person meeting the inclusion criteria for the device may be included in this study. These patients tend to be those seeking relief from painful or debilitating knee joint disease.
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked, the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered would be collated and used to provide feedback to design engineers, support marketing efforts, and answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented by asking the surgeon to document revisions and complications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754637
|United States, Michigan|
|The DeClaire Knee & Orthopaedic Institute|
|Rochester Hills, Michigan, United States, 48307|
|Study Director:||Ken Beres, MD||Biomet, Inc.|