Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03991728
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AO Clinical Investigation and Documentation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andreas Thor, MDVinay V Kumar, MD
Principal Investigator Affiliation Oral and Maxillofacial surgery Uppsala University HospitalOral and Maxillofacial surgery Uppsala University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Brazil, Colombia, Finland, Germany, India, Netherlands, New Zealand, Pakistan, Russian Federation, South Africa, Spain, Sweden, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Temporomandibular Joint Disorders
Additional Details

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

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Texas Health, San Antonio, Texas

Status

Not yet recruiting

Address

University of Texas Health

San Antonio, Texas, 78229

Site Contact

Daniel Pérez, MD

[email protected]

+41 81 414 25 10

International Sites

São Paulo, Brazil

Status

Active, not recruiting

Address

Hospital BP - A Beneficência Portuguesa de São Paulo

São Paulo, ,

Estetica Maxilofacial, Bogotá, Colombia

Status

Not yet recruiting

Address

Estetica Maxilofacial

Bogotá, ,

Site Contact

Fernando Briceno, MD

[email protected]

+41 81 414 25 10

Helsinki University Hospital, Helsinki, Finland

Status

Address

Helsinki University Hospital

Helsinki, ,

Universitätsklinikum Düsseldorf (UKD), Düsseldorf, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Düsseldorf (UKD)

Düsseldorf, , 40225

Site Contact

Majeed Rana, MD

[email protected]

+41 81 414 25 10

Hannover Medical School, Hannover, Germany

Status

Not yet recruiting

Address

Hannover Medical School

Hannover, , 30625

Site Contact

Rüdiger Zimmerer, MD

[email protected]

+41 81 414 25 10

Klinikum der LMU München, Munich, Germany

Status

Address

Klinikum der LMU München

Munich, , 80337

New Delhi, India

Status

Not yet recruiting

Address

All India Institute of Medical Sciences (AIIMS)

New Delhi, , 110029

Site Contact

Ajoy Roychoudhury, MD

[email protected]

+41 81 414 25 10

Erasmus Medisch Centrum, Rotterdam, Netherlands

Status

Not yet recruiting

Address

Erasmus Medisch Centrum

Rotterdam, , 3075

Site Contact

Eppo Wolvius, MD

[email protected]

+41 81 414 25 10

Waikato DHB, Christchurch, New Zealand

Status

Active, not recruiting

Address

Waikato DHB

Christchurch, ,

Hutt Hospital, Lower Hutt, New Zealand

Status

Active, not recruiting

Address

Hutt Hospital

Lower Hutt, ,

Mayo Hospital, Lahore, Pakistan

Status

Active, not recruiting

Address

Mayo Hospital

Lahore, ,

Moscow, Russian Federation

Status

Active, not recruiting

Address

National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

Moscow, ,

King Edward VIII Hospital, Durban, South Africa

Status

Not yet recruiting

Address

King Edward VIII Hospital

Durban, , 4030

Site Contact

Vivesh Rughubar, MD

[email protected]

+41 81 414 25 10

12 de Octubre University Hospital, Madrid, Spain

Status

Not yet recruiting

Address

12 de Octubre University Hospital

Madrid, , 28041

Site Contact

Gregorio S. Aniceto, MD

[email protected]

+41 81 414 25 10

Falu Hospital, Falun, Sweden

Status

Not yet recruiting

Address

Falu Hospital

Falun, , 79182

Site Contact

Jani Talvilahti, MD

[email protected]

+41 81 414 25 10

Skåne University Hospital, Lund, Sweden

Status

Address

Skåne University Hospital

Lund, ,

Karolinska University Hospital, Stockholm, Sweden

Status

Active, not recruiting

Address

Karolinska University Hospital

Stockholm, ,

Uppsala University Hospital, Uppsala, Sweden

Status

Not yet recruiting

Address

Uppsala University Hospital

Uppsala, , SE-75185

Site Contact

Andreas Thor, MD

[email protected]

+46 (0)18 611 6450

Universitätsspital Basel, Basel, Switzerland

Status

Not yet recruiting

Address

Universitätsspital Basel

Basel, ,

Site Contact

Florian Thieringer, MD

[email protected]

+41 81 414 25 10