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Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 9 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 18 of 20 entries
    • Site details revised at 1 of 23 sites
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv21
  3. Study sites: 22 to 23v20
  4. Lead sponsor: AO Clinical Investigation and Publishing Documentation to AO Innovation Translation Center
    • Study sites: 21 to 22
    v19
  5. Re-verified, no change to tracked fieldsv18
Show 16 earlier versionsHide 16 earlier versions
  1. Primary completion date: Dec 2026 to Sep 2032
    • Study completion date: Dec 2027 to Dec 2033
    v17
  2. Study sites: 23 to 21v16
  3. Re-verified, no change to tracked fieldsv15
  4. Study sites: 22 to 23v14
  5. Site details revised at 2 of 22 sitesv13
  6. Re-verified, no change to tracked fieldsv12
  7. Site details revised at 1 of 22 sitesv11
  8. Site details revised at 1 of 22 sitesv10
  9. Study sites: 21 to 22v9
  10. Site details revised at 4 of 21 sitesv8
  11. Study sites: 19 to 21v7
  12. Re-verified, no change to tracked fieldsv6
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 20 to 19
    • Start date changed from estimate of Nov 2019 to Oct 15, 2019
    v5
  14. Study sites: 14 to 20v4
  15. Start date: Aug 2019 to Nov 2019v3
  16. Secondary endpoints: details revised at 7 of 20 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications). This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.
Trial Details
NCT Number NCT03991728
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Temporomandibular Joint Disorders
Related terms Ankylosis, Joint Diseases, Temporomandibular Joint Disorders, Wounds and Injuries
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov