Total Temporomandibular Joint Replacement System Post Approval Study

Arthroplasty Clinical Trial

Official title:

Survivibility of the Total Temporomandibular Joint Replacement System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762944
• Other study ID #: BMET WL 01
• Status: Completed
• Start date: September 21, 2005
• Est. completion date: September 21, 2008

Study information

• Verified date: March 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 21, 2008
• Est. primary completion date: August 25, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty

Intervention

Device:
• Biomet TMJ Replacement System
Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System

Locations

Country	Name	City	State
United States	The University of Texas,Southwestern Medical School	Dallas	Texas
United States	Riley Hospital	Indianapolis	Indiana
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Jeffrey S. Topf, D.D.S.	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Revision	Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)	3 years
Secondary	jaw pain intensity (VAS score)	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	1 year, 1.5 years
Secondary	Interference with eating	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	1 year, 1.5 years
Secondary	Maximun Incisal Opening	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.	1 year, 1.5 years
Secondary	Patient Satisfaction	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"	6 months, 1 year, 1.5 years, and 3 years