Status:
COMPLETED
Regenerex Tibial Tray Multi-Center Data Collection
Lead Sponsor:
Zimmer Biomet
Conditions:
Pain
Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.
Detailed Description
See Protocol
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00859963
Start Date
March 1 2009
End Date
December 1 2018
Last Update
October 27 2021
Active Locations (6)
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1
Stanford University, Department of Orthopedics
Stanford, California, United States, 94305
2
Midwest Orthopedics at RUSH University
Chicago, Illinois, United States, 60612
3
Physicians Clinic of Iowa
Cedar Rapids, Iowa, United States, 52403
4
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207