Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Microplasty Tibial Tray Data Collection (MTT)

This study has been withdrawn prior to enrollment.
(The study was withdrawn because it no longer fit the business need.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00754637
First received: September 17, 2008
Last updated: January 25, 2012
Last verified: January 2012

September 17, 2008
January 25, 2012
December 2009
December 2022   (final data collection date for primary outcome measure)
Knee Society Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Survivorship [ Time Frame: From Operation to 10 years post-op ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00754637 on ClinicalTrials.gov Archive Site
Radiographic Data [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Knee Society Score [ Time Frame: Preop, 6 months, 1 Year, 3 Years, 5 Years, 7 Years, 10 Years ] [ Designated as safety issue: No ]
  • UCLA Score, Radiographic Record, & EQ-5D [ Time Frame: Preop, 0-6 Weeks, 6 months, 1 Year, 3 Years, 5 Years, 7 Years, 10 Years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Microplasty Tibial Tray Data Collection
Microplasty Tibial Tray Multi-Center Data Collection

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.

Joint Disease
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2023
December 2022   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00754637
335
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Study Director: Ken Beres, MD Biomet, Inc.
Biomet, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP