NCT03991728 Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
| NCT ID | NCT03991728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AO Innovation Translation Center |
| Condition | Temporomandibular Joint Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-10-15 |
| Primary Completion | 2032-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-10-15 with a primary completion date of 2032-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18 years and or older * Patients requiring alloplastic total TMJ replacement * Informed consent obtained, i.e.: * Ability to understand the content of the patient information/informed consent form (ICF) * Willingness and ability to participate in the registry according to the Registry Plan (RP) * Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent Exclusion Criteria: * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the study period * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Contact & Investigator
Andreas Thor, MD
PRINCIPAL INVESTIGATOR
Oral and Maxillofacial surgery Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT03991728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Temporomandibular Joint Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03991728 currently recruiting?
Yes, NCT03991728 is actively recruiting participants. Contact the research team at viola.gruenenfelder@aofoundation.org for enrollment information.
Where is the NCT03991728 trial being conducted?
This trial is being conducted at São Paulo, Brazil, Bogotá, Colombia, Copenhagen, Denmark, Hanover, Germany and 11 additional locations.
Who is sponsoring the NCT03991728 clinical trial?
NCT03991728 is sponsored by AO Innovation Translation Center. The principal investigator is Andreas Thor, MD at Oral and Maxillofacial surgery Uppsala University Hospital. The trial plans to enroll 200 participants.