Microplasty Tibial Tray Data Collection

Joint Disease Clinical Trial

— MTT  

Official title:

Microplasty Tibial Tray Multi-Center Data Collection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00754637
• Other study ID #: 335
• Status: Withdrawn
• Phase: N/A
• First received: September 17, 2008
• Last updated: June 19, 2017
• Start date: December 2009
• Est. completion date: June 2023

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Locations

Country	Name	City	State
United States	The DeClaire Knee & Orthopaedic Institute	Rochester Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Brooks, et al. (Eds.). (2003) The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Netherlands: Kluwer Academic Publishers.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		5 years
Secondary	Radiographic Data		10 Years