Total Temporomandibular Joint Replacement System Post Approval Study

Completed

• Conditions: Arthroplasty
• Interventions: Device: Biomet TMJ Replacement System

• Registration Number: NCT00762944
• Lead Sponsor: Zimmer Biomet

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 \[PMA P020016\].

Study Timeline

• Study Start: 2005-09-21
• Primary Completion: 2008-08-25
• Study Completion: 2008-09-21
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomet TMJ Replacement System	Biomet TMJ Replacement System	All patients required total reconstruction of the temporomandibular joint (unilateral or billateral)

Primary Outcome Measures

Name	Time	Method
Time to Revision	3 years	Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)

Secondary Outcome Measures

Name	Time	Method
jaw pain intensity (VAS score)	1 year, 1.5 years	Pain level is recored in a 10 cm line according the intensity of pain, where zero on the far left represents "no pain" and 10 on the far right, represent the maximum level of pain experienced
Interference with eating	1 year, 1.5 years	Interference of eating is recored in a 10 cm line according the intensity of the interference with eating, where zero on the far left represents "no interference with eating" and 10 on the far right, represent the maximum level of interference with eating experienced
Maximun Incisal Opening	1 year, 1.5 years	Maximum Incisal Opening (MIO) is the distance measured in millimeters (mm) from the incisal edge of the maxillary central incisors to the incisal edge of the mandibular central incisors at the midline with the mouth wide open.
Patient Satisfaction	6 months, 1 year, 1.5 years, and 3 years	Patient satisfaction is the level of comfort with the TMJ reconstruction that a given patient experiences. It is expressed as "very satisfied", "satisfied", "dissatisfied" or "failure"

Trial Locations

Locations (4)

Riley Hospital; 🇺🇸 Indianapolis, Indiana, United States

The University of Texas,Southwestern Medical School; 🇺🇸 Dallas, Texas, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Jeffrey S. Topf, D.D.S.; 🇺🇸 West Bloomfield, Michigan, United States