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Sponsored by: |
Biomet, Inc. |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00754637 |
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
Condition |
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Joint Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Microplasty Tibial Tray Multi-Center Data Collection |
Estimated Enrollment: | 200 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | June 2023 |
Estimated Primary Completion Date: | December 2022 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.
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.
Contact: Nick Higdon, MS | 574-371-3047 | nick.higdon@biomet.com |
Contact: Ken Beres, MD | 1-800-348-9500 ext 1691 | ken.beres@biomet.com |
Responsible Party: | Biomet, LLC ( Ken Beres, Director of Clinical Research ) |
Study ID Numbers: | 335 |
Study First Received: | September 17, 2008 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00754637 History of Changes |
Health Authority: | United States: Institutional Review Board |
Joint Osteoarthritis Avascular Necrosis |
Necrosis Musculoskeletal Diseases Osteonecrosis Osteoarthritis Joint Diseases |
Musculoskeletal Diseases Joint Diseases |