Status:
WITHDRAWN
Microplasty Tibial Tray Data Collection
Lead Sponsor:
Zimmer Biomet
Conditions:
Joint Disease
Eligibility:
All Genders
18+ years
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 accorda...
Eligibility Criteria
Inclusion
- 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
- 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:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- Metabolic disorders which may impair bone formation,
- Osteomalacia,
- Distant foci of infections which may spread to the implant site,
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
- Vascular insufficiency, muscular atrophy, neuromuscular disease,
- Incomplete or deficient soft tissue surrounding the knee.
- Biomet Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00754637
Start Date
December 1 2009
End Date
June 1 2023
Last Update
June 21 2017
Active Locations (1)
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1
The DeClaire Knee & Orthopaedic Institute
Rochester Hills, Michigan, United States, 48307