Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

NCT03991728 · tracked via the Priya Life Science India tracker

Sponsor

AO Innovation Translation Center

Phase

Observational

Started

2019-10-15

Last updated

2026-09-16

Condition(s) studied

Temporomandibular Joint Disorders

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The registry has no primary but several objectives. — from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
due to the study design, no primary objective has been defined and therefore no primary outcome measure either

Trial sites (23)

Facility	City	Region	Status
Hospital BP - A Beneficência Portuguesa de São Paulo	São Paulo	Brazil	Recruiting
Estetica Maxilofacial	Bogotá	Colombia	Suspended
Rigshospitalet	Copenhagen	Denmark	Recruiting
Hannover Medical School	Hanover	Germany	Recruiting
University Hospital Leipzig	Leipzig	Germany	Recruiting
Klinikum der Johannes Gutenberg Universität Mainz	Mainz	Germany	Not Yet Recruiting
Klinikum der LMU München	Munich	Germany	Recruiting
Sri Shankara Cancer Hospital and Research Center	Bangalore	India	Recruiting
All India Institute of Medical Sciences (AIIMS)	New Delhi	India	Terminated
Erasmus Medisch Centrum	Rotterdam	Netherlands	Recruiting
Waikato DHB	Christchurch	New Zealand	Terminated
Hutt Hospital	Lower Hutt	New Zealand	Suspended
Mayo Hospital	Lahore	Pakistan	Terminated
Wojewódzki Specjalistyczny Szpital Dziecięcy	Olsztyn	Poland	Recruiting
National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation	Moscow	Russia	Recruiting
Clinic for Maxillofacial Surgery, University of Belgrade	Belgrade	Serbia	Recruiting
King Edward VIII Hospital	Durban	South Africa	Recruiting
12 de Octubre University Hospital	Madrid	Spain	Recruiting
Falu Hospital	Falun	Sweden	Recruiting
Skåne University Hospital	Lund	Sweden	Recruiting
Karolinska University Hospital	Stockholm	Sweden	Recruiting
Uppsala University Hospital	Uppsala	Sweden	Recruiting
Universitätsspital Basel	Basel	Switzerland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03991728 on ClinicalTrials.gov ↗ ← All trials in India