Microplasty Tibial Tray Data Collection (MTT)

• ClinicalTrials.gov Identifier: NCT00754637
• Recruitment Status: Withdrawn
• First Posted: September 18, 2008
• Last Update Posted: June 21, 2017
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Tracking Information

• First Submitted Date: September 17, 2008
• First Posted Date: September 18, 2008
• Last Update Posted Date: June 21, 2017
• Study Start Date: December 2009
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 7, 2009): Knee Society Score [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: September 17, 2008): Survivorship [ Time Frame: From Operation to 10 years post-op ]
• Current Secondary Outcome Measures (submitted: July 7, 2009): Radiographic Data [ Time Frame: 10 Years ]

Original Secondary Outcome Measures (submitted: September 17, 2008)

• Knee Society Score [ Time Frame: Preop, 6 months, 1 Year, 3 Years, 5 Years, 7 Years, 10 Years ]
• UCLA Score, Radiographic Record, & EQ-5D [ Time Frame: Preop, 0-6 Weeks, 6 months, 1 Year, 3 Years, 5 Years, 7 Years, 10 Years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Microplasty Tibial Tray Data Collection
• Official Title: Microplasty Tibial Tray Multi-Center Data Collection
• Brief Summary: The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.
• Condition: Joint Disease
• Intervention: Not Provided

Study Groups/Cohorts

510(k) Inclusion Criteria

Any person meeting the inclusion criteria for the device may be included in this study. These patients tend to be those seeking relief from painful or debilitating knee joint disease.

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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 25, 2012): 0
• Original Estimated Enrollment (submitted: September 17, 2008): 200
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00754637
• Other Study ID Numbers: 335
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Zimmer Biomet
• Study Sponsor: Zimmer Biomet
• Collaborators: Not Provided

Investigators

• Study Director: Ken Beres, MD; Zimmer Biomet

• PRS Account: Zimmer Biomet
• Verification Date: June 2017