Regenerex Tibial Tray Multi-Center Data Collection



Status:Enrolling by invitation
Conditions:Arthritis, Arthritis, Chronic Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/9/2018
Start Date:March 2009
End Date:December 2018

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

See Protocol

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.
We found this trial at
6
sites
Chicago, Illinois 60612
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Chicago, IL
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Cedar Rapids, Iowa 52401
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Cedar Rapids, IA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Danville, Pennsylvania 17822
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Danville, PA
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Stanford, CA
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Virginia Beach, Virginia 23462
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Virginia Beach, VA
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