Joint Disease
Conditions
Keywords
Joint, Osteoarthritis, Avascular Necrosis
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus, or posttraumatic deformity. * Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Patient selection factors to be considered include: * Need to obtain pain relief and improve function * Ability and willingness of the patient to follow instructions, including control of weight and activity level * A good nutritional state of the patient, and * The patient must have reached full skeletal maturity Non-coated (Interlock®) devices are indicated for cemented application only.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Data | 10 Years |
Countries
United States
Outcome results
None listed