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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

Brief Summary:
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data

Condition or disease
Arthroplasty

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Total Temporomandibular Joint Replacement System Post Approval Study
Study Start Date : September 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008



Primary Outcome Measures :
  1. jaw pain intensity (VAS score), interference with eating, mouth opening [ Time Frame: 3 yr ]

Secondary Outcome Measures :
  1. jaw pain intensity (VAS score), interference with eating, mouth opening [ Time Frame: 1yr, 1.5yr ]
  2. Patient Satisfaction [ Time Frame: 6m, 1 yr, 1.5 yr, and 3 yr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received TMJ systems from the IDE study
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762944


Locations
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United States, Indiana
Riley Hospital
Indianapolis, Indiana, United States
United States, Michigan
Jeffrey S. Topf, D.D.S.
West Bloomfield, Michigan, United States
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
The University of Texas,Southwestern Medical School
Dallas, Texas, United States
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kim Reed Biomet Microfixation
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00762944    
Other Study ID Numbers: BMET WL 01
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011
Keywords provided by Zimmer Biomet:
Patients requiring total joint reconstruction due to:
Arthritis (osteo-, rheumatoid, traumatic) malignancy
Ankylosis functional deformity
Avascular necrosis revisions
Benign neoplasms fracture
Multiple operated joints