Total Temporomandibular Joint Replacement System Post Approval Study

Survivibility of the Total Temporomandibular Joint Replacement System

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty
• Intervention / Treatment: Device: Biomet TMJ Replacement System

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital
  • Michigan
    • West Bloomfield, Michigan, United States, 48322
      • Jeffrey S. Topf, D.D.S.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas,Southwestern Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received TMJ systems from the IDE study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biomet TMJ Replacement System; All patients required total reconstruction of the temporomandibular joint (unilateral or billateral)	Device: Biomet TMJ Replacement System; Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System; Other Names: TMJ alloplastic reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Revision	Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Chair: Oscar A Gonzalez, MD, DNP, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2005
• Primary Completion (Actual): August 25, 2008
• Study Completion (Actual): September 21, 2008

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimated): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: BMET WL 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No