Regenerex Tibial Tray Multi-Center Data Collection
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Arthritis
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Ken Beres, MD, Study Director, Affiliation: Biomet Orthopedics, LLC
Overall contact:
Carol Lauster, Phone: 574-372-1913
Summary
The purpose of this prospective clinical data collection is to document the performance and
clinical outcomes of the Regenerex™ Tibial Tray.
Clinical Details
Official title: Regenerex Tibial Tray Multi-Center Data Collection
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Knee Society Score
Secondary outcome: Survivorship
Detailed description:
See Protocol
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Carol Lauster, Phone: 574-372-1913
Stanford University, Department of Orthopedics, Stanford, California 94305, United States; Recruiting
Midwest Orthopedics at RUSH University, Chicago, Illinois 60612, United States; Recruiting
Physicicans Clinic of Iowa, Cedar Rapids, Iowa 52403, United States; Recruiting
The DeClaire Kne & Orthopaedic Institute, Rochester Hills, Michigan 48307, United States; Recruiting
Jeffrey DeClaire, MD, Principal Investigator
Jignesh Patel, MD, Sub-Investigator
Additional Information
Starting date: March 2009
Last updated: June 1, 2010
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