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Microplasty Tibial Tray Data Collection (MTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754637
Recruitment Status : Withdrawn (The study was withdrawn because it no longer fit the business need.)
First Posted : September 18, 2008
Last Update Posted : June 21, 2017
Sponsor:
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 ]
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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