Regenerex Tibial Tray Multi-Center Data Collection

Zimmer Biomet6 sites in 1 country102 target enrollmentMarch 2009

Overview

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

See Protocol

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

December 2018

Last Updated

4 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K
•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, or arthrodesis.
•Patient selection factors to be considered include:
•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

•The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K
•These contraindications are stated below:
•Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
•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,