Regenerex Tibial Tray Multi-Center Data Collection

Launched by ZIMMER BIOMET · Mar 10, 2009

Keywords

ClinConnect Summary

See Protocol

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below:
• • 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• • 2. Correction of varus, valgus, or posttraumatic deformity.
• • 3. Correction or revision of unsuccessful osteotomy, or arthrodesis.
• Patient selection factors to be considered include:
• • 1. Ability and willingness of the patient to follow instructions, including control of weight and activity level
• • 2. A good nutritional state of the patient, and
• • 3. The patient must have reached full skeletal maturity
• Exclusion Criteria:
• The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below:
• • Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
• * Relative contraindications include:
• • 1. Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
• • 2. Osteoporosis,
• • 3. Metabolic disorders which may impair bone formation,
• • 4. Osteomalacia,
• • 5. Distant foci of infections which may spread to the implant site,
• • 6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
• • 7. Vascular insufficiency, muscular atrophy, neuromuscular disease,
• • 8. Incomplete or deficient soft tissue surrounding the knee.