NCT00762944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2008

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

September 26, 2008

Last Update Submit

June 20, 2024

Conditions

Arthroplasty

Keywords

Patients requiring total joint reconstruction due to:Arthritis (osteo-, rheumatoid, traumatic) malignancyAnkylosis functional deformityAvascular necrosis revisionsBenign neoplasms fractureMultiple operated joints

Outcome Measures

Primary Outcomes (1)

  • Time to Revision

    Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)

    3 years

Secondary Outcomes (4)

  • jaw pain intensity (VAS score)

    1 year, 1.5 years

  • Interference with eating

    1 year, 1.5 years

  • Maximun Incisal Opening

    1 year, 1.5 years

  • Patient Satisfaction

    6 months, 1 year, 1.5 years, and 3 years

Study Arms (1)

Biomet TMJ Replacement System

All patients required total reconstruction of the temporomandibular joint (unilateral or billateral)

Device: Biomet TMJ Replacement System

Interventions

Biomet TMJ Replacement SystemDEVICE

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

Also known as: TMJ alloplastic reconstruction
Biomet TMJ Replacement System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received TMJ systems from the IDE study

You may qualify if:

  • Patients requiring total joint reconstruction due to:
  • Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
  • Patients who are skeletally mature.
  • Patients must have at least one of the following criteria for surgical TMJ treatment.
  • Presence of considerable pain and/or limited function in the joint area.
  • Clinical and imaging evidence consistent with anatomic joint pathology
  • Previous failure of non-surgical treatment/therapy or a failed implant.
  • High probability of patient improvement by surgical treatment.
  • Patients must be able to return for follow-up examinations.
  • Patients without serious compromising general medical conditions.

You may not qualify if:

  • Patients with active infection.
  • Patient conditions where there is insufficient quantity or quality of bone to support the device
  • Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
  • Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
  • Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
  • Patients who are NOT skeletally mature.
  • Patients who are incapable or unwilling to follow postoperative care instructions.
  • Patients who are unable to return for follow-up examinations.
  • Patients with severe hyper-functional habits
  • Patients on chronic steroid therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

Jeffrey S. Topf, D.D.S.

West Bloomfield, Michigan, 48322, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas,Southwestern Medical School

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

ArthritisNeoplasms

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Oscar A Gonzalez, MD, DNP

    Zimmer Biomet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

September 21, 2005

Primary Completion

August 25, 2008

Study Completion

September 21, 2008

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

US(4)