NCT03991728

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

More in detail this registry has the following objectives: * To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible) * To describe the clinical evolution and outcomes of patients treated with a TMJ replacement * To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL). * To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement. * To describe the reasons of patients who refused TMJ replacements

Conditions

• Temporomandibular Joint Disorders

Timeline

• Start date: 2019-10-15
• Primary completion: 2032-09-01
• Completion: 2033-12-01
• First posted: 2019-06-19
• Last updated: 2026-02-18

Locations

23 sites across 15 countries: Brazil, Colombia, Denmark, Germany, India, Netherlands, New Zealand, Pakistan, Poland, Russia, Serbia, South Africa, Spain, Sweden, Switzerland