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Total Temporomandibular Joint Replacement System Post Approval Study

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: NCT00762944
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 19, 2011
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date September 26, 2008
First Posted Date September 30, 2008
Last Update Posted Date October 19, 2011
Study Start Date September 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2008)
jaw pain intensity (VAS score), interference with eating, mouth opening [ Time Frame: 3 yr ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2008)
  • jaw pain intensity (VAS score), interference with eating, mouth opening [ Time Frame: 1yr, 1.5yr ]
  • Patient Satisfaction [ Time Frame: 6m, 1 yr, 1.5 yr, and 3 yr ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Total Temporomandibular Joint Replacement System Post Approval Study
Official Title Total Temporomandibular Joint Replacement System Post Approval Study
Brief Summary Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data
Detailed Description Not Provided
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 who received TMJ systems from the IDE study
Condition Arthroplasty
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2008)
92
Original Actual Enrollment Same as current
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients requiring total joint reconstruction due to:

    Arthritis (osteo-, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints

  2. Patients who are skeletally mature.
  3. Patients must have at least one of the following criteria for surgical TMJ treatment.

    1. Presence of considerable pain and/or limited function in the joint area.
    2. Clinical and imaging evidence consistent with anatomic joint pathology
    3. Previous failure of non-surgical treatment/therapy or a failed implant.
    4. High probability of patient improvement by surgical treatment.
  4. Patients must be able to return for follow-up examinations.
  5. Patients without serious compromising general medical conditions.

Exclusion Criteria:

  1. Patients with active infection.
  2. Patient conditions where there is insufficient quantity or quality of bone to support the device
  3. Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
  4. Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
  5. Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
  6. Patients who are NOT skeletally mature.
  7. Patients who are incapable or unwilling to follow postoperative care instructions.
  8. Patients who are unable to return for follow-up examinations.
  9. Patients with severe hyper-functional habits
  10. Patients on chronic steroid therapy.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, 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 NCT00762944
Other Study ID Numbers BMET WL 01
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: Kim Reed Biomet Microfixation
PRS Account Zimmer Biomet
Verification Date October 2011