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Total Temporomandibular Joint Replacement System Post Approval Study


N/A
N/A
N/A
Not Enrolling
Both
Arthroplasty

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Trial Information

Total Temporomandibular Joint Replacement System Post Approval Study


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

jaw pain intensity (VAS score), interference with eating, mouth opening

Outcome Time Frame:

3 yr

Safety Issue:

No

Principal Investigator

Kim Reed

Investigator Role:

Study Director

Investigator Affiliation:

Biomet Microfixation

Authority:

United States: Institutional Review Board

Study ID:

BMET WL 01

NCT ID:

NCT00762944

Start Date:

September 2005

Completion Date:

September 2008

Related Keywords:

  • Arthroplasty
  • Patients requiring total joint reconstruction due to:
  • Arthritis (osteo-, rheumatoid, traumatic) malignancy
  • Ankylosis functional deformity
  • Avascular necrosis revisions
  • Benign neoplasms fracture
  • Multiple operated joints

Name

Location

Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Riley HospitalIndianapolis, Indiana  
Jeffrey S. Topf, D.D.S.West Bloomfield, Michigan  
The University of Texas,Southwestern Medical SchoolDallas, Texas