Regenerex Tibial Tray Multi-Center Data Collection
Completed
Conditions studied: Pain, Arthritis
In brief
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.
Key facts
- Study ID
- NCT00859963
- Run by
- Zimmer Biomet
- People needed
- 102
- Starts
- 2009-03-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2021-10-27
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 (cleared in 510(k) K080361. 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
You may not qualify if…
- 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:
- 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.
Where it is running
- Stanford University, Department of Orthopedics — Stanford, California, United States
- Midwest Orthopedics at RUSH University — Chicago, Illinois, United States
- Physicians Clinic of Iowa — Cedar Rapids, Iowa, United States
- OrthoCarolina Research Institute — Charlotte, North Carolina, United States
- Geisinger Health System — Danville, Pennsylvania, United States
- Jordan-Young Institute — Virginia Beach, Virginia, United States
Full record on ClinicalTrials.gov
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