Microplasty Tibial Tray Data Collection

Withdrawn before enrolling

Conditions studied: Joint Disease

In brief

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.

Key facts

Study ID

NCT00754637

Run by

Zimmer Biomet

People needed

0

Starts

2009-12-01

Expected to finish

2023-06-01

Last updated by the study team

2017-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The DeClaire Knee & Orthopaedic Institute — Rochester Hills, Michigan, United States

Full record on ClinicalTrials.gov

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