Microplasty Tibial Tray Data Collection
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Joint Disease
Phase: N/A
Status: Not yet recruiting
Sponsored by: Biomet, Inc. Overall contact:
Nick Higdon, MS, Phone: 574-371-3047, Email: nick.higdon@biomet.com
Summary
The purpose of this prospective clinical data-collection is to document the performance and
clinical outcomes of the Microplasty Tibial Tray.
Clinical Details
Official title: Microplasty Tibial Tray Multi-Center Data Collection
Study design: Cohort, Prospective
Primary outcome: Knee Society Score
Secondary outcome: Radiographic Data
Detailed description:
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked,
the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive
93/42/EEC; in accordance to 13485: 2003. The data gathered would be collated and used to
provide feedback to design engineers, support marketing efforts, and answer potential
questions from reimbursement agencies, and will serve as a part of Biomet's Post Market
Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated
in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and
patient care are to be standard for the surgeon participating in the protocol and should be
maintained the same throughout the course of the data-collection. There will be no
experimental or investigational devices used. There will be no experimental or
investigational surgical techniques used. The devices and products will be used in
accordance with their instructions for use and/or approved labeling. Any use of the device
or collection of clinical data outside of the United States should comply with all local,
state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented
by asking the surgeon to document revisions and complications.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
The inclusion criteria will be identical to the indications stated in the FDA approved
labeling for the device in 510(k) K063732. 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, arthrodesis, or failure of previous
joint replacement procedure.
Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
- 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
Non-coated (Interlock®) devices are indicated for cemented application only.
Exclusion Criteria:
The exclusion criteria will be identical to the contraindications stated in the FDA
approved labeling for the device in 510(k) K063732. These contraindications are stated
below:
Absolute contraindications include: infection, sepsis, and osteomyelitis.
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.
Biomet Microplastyâ„¢ Tibial Trays are contraindicated for use with constrained bearings.
Locations and Contacts
Nick Higdon, MS, Phone: 574-371-3047, Email: nick.higdon@biomet.com Additional Information
Related publications: Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4. Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41. Brooks, et al. (Eds.). (2003) The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Netherlands: Kluwer Academic Publishers.
Starting date: July 2009
Ending date: June 2023
Last updated: July 7, 2009
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