Microplasty Tibial Tray Data Collection (MTT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00754637 |
Recruitment Status :
Withdrawn
(The study was withdrawn because it no longer fit the business need.)
First Posted : September 18, 2008
Last Update Posted : June 21, 2017
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Tracking Information | ||||
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First Submitted Date | September 17, 2008 | |||
First Posted Date | September 18, 2008 | |||
Last Update Posted Date | June 21, 2017 | |||
Study Start Date | December 2009 | |||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Knee Society Score [ Time Frame: 5 years ] | |||
Original Primary Outcome Measures |
Survivorship [ Time Frame: From Operation to 10 years post-op ] | |||
Change History | ||||
Current Secondary Outcome Measures |
Radiographic Data [ Time Frame: 10 Years ] | |||
Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Microplasty Tibial Tray Data Collection | |||
Official Title | Microplasty Tibial Tray Multi-Center Data Collection | |||
Brief Summary | The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray. | |||
Detailed Description | 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. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device. | |||
Condition | Joint Disease | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | 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.
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Publications * |
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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 | Withdrawn | |||
Actual Enrollment |
0 | |||
Original Estimated Enrollment |
200 | |||
Estimated Study Completion Date | June 2023 | |||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device in 510(k) K063732. These indications are stated below:
Patient selection factors to be considered include:
Non-coated (Interlock®) devices are indicated for cemented application only. Exclusion Criteria: The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device in 510(k) K063732. These contraindications are stated below: Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include:
Biomet Microplasty™ Tibial Trays are contraindicated for use with constrained bearings. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00754637 | |||
Other Study ID Numbers | 335 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Zimmer Biomet | |||
Study Sponsor | Zimmer Biomet | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Zimmer Biomet | |||
Verification Date | June 2017 |