CompletedNot Applicable

Total Temporomandibular Joint Replacement System Post Approval Study

United States93 participantsStarted 2005-09-21

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients requiring total joint reconstruction due to:
✓. 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 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.

Time to Revision

Timeframe: 3 years

NCT IDNCT00762944

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2008-08-25