Regenerex Tibial Tray Multi-Center Data Collection

Zimmer Biomet

Status: Completed

Conditions: Arthritis; Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT00859963

ORTHO.CR.ROWG2 (US 25)

Details and patient eligibility

About

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

Full description

See Protocol

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.