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

Status: Recruiting
Location: See all (23) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Hospital BP - A Beneficência Portuguesa de São Paulo
RECRUITING
São Paulo
Colombia
Estetica Maxilofacial
SUSPENDED
Bogotá
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Germany
Hannover Medical School
RECRUITING
Hanover
University Hospital Leipzig
RECRUITING
Leipzig
Klinikum der Johannes Gutenberg Universität Mainz
NOT_YET_RECRUITING
Mainz
Klinikum der LMU München
RECRUITING
Munich
India
Sri Shankara Cancer Hospital and Research Center
RECRUITING
Bangalore
All India Institute of Medical Sciences (AIIMS)
TERMINATED
New Delhi
Netherlands
Erasmus Medisch Centrum
RECRUITING
Rotterdam
New Zealand
Waikato DHB
TERMINATED
Christchurch
Hutt Hospital
SUSPENDED
Lower Hutt
Pakistan
Mayo Hospital
TERMINATED
Lahore
Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy
RECRUITING
Olsztyn
Russian Federation
National Medical and Surgical Center named after N.I. Pirogov of the Ministry of Healthcare of the Russian Federation
RECRUITING
Moscow
Serbia
Clinic for Maxillofacial Surgery, University of Belgrade
RECRUITING
Belgrade
South Africa
King Edward VIII Hospital
RECRUITING
Durban
Spain
12 de Octubre University Hospital
RECRUITING
Madrid
Sweden
Falu Hospital
RECRUITING
Falun
Skåne University Hospital
RECRUITING
Lund
Karolinska University Hospital
RECRUITING
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
Switzerland
Universitätsspital Basel
RECRUITING
Basel
Contact Information
Primary
Viola Grünenfelder
viola.gruenenfelder@aofoundation.org
+41 79 696 33 97
Backup
Aleksandra Hodor
aleksandra.hodor@aofoundation.org
Time Frame
Start Date: 2019-10-15
Estimated Completion Date: 2033-12
Participants
Target number of participants: 200
Treatments
Alloplastic total TMJ replacement
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.
Sponsors
Leads: AO Innovation Translation Center

This content was sourced from clinicaltrials.gov