Clinical trial NCT00762944: Total Temporomandibular Joint Replacement System Post Approval Study
Official title: Survivibility of the Total Temporomandibular Joint Replacement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Keywords: Patients requiring total joint reconstruction due to:
Arthritis (osteo-, rheumatoid, traumatic) malignancy
Ankylosis functional deformity
Avascular necrosis revisions
Benign neoplasms fracture
Multiple operated joints
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received TMJ systems from the IDE study

Brief summary: Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data \[PMA P020016\]

Detailed description: An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval \[PMA P020016\].

Eligibility criteria: Inclusion Criteria:

1. Patients requiring total joint reconstruction due to:

   Arthritis (osteoarthritis, 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.

Primary outcomes:
measure: Time to Revision
timeFrame: 3 years
Secondary outcomes:
measure: jaw pain intensity (VAS score)
timeFrame: 1 year, 1.5 years
measure: Interference with eating
timeFrame: 1 year, 1.5 years
measure: Maximun Incisal Opening
timeFrame: 1 year, 1.5 years
measure: Patient Satisfaction
timeFrame: 6 months, 1 year, 1.5 years, and 3 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital
state: Indiana
city: West Bloomfield
country: United States
facility: Jeffrey S. Topf, D.D.S.
state: Michigan
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: The University of Texas,Southwestern Medical School
state: Texas
Study officials:
affiliation: Zimmer Biomet
name: Oscar A Gonzalez, MD, DNP
role: STUDY_CHAIR
References: