Registry for patients undergoing TMJ replacement
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
AO Innovation Translation Center · NCT03991728
This study is tracking around 200 patients who are getting a new jaw joint to see how the treatment affects their quality of life and what factors lead to better results over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center (other) |
| Locations | 23 sites (São Paulo and 22 other locations) |
| Trial ID | NCT03991728 on ClinicalTrials.gov |
What this trial studies
This registry collects prospective data from approximately 200 patients who are treated with alloplastic total temporomandibular joint (TMJ) replacement. Participants will be followed for up to 5 years to assess clinical indications, treatment patterns, and patient-reported outcomes. The study aims to explore the relationship between treatment and quality of life, identify predictive factors for favorable outcomes, and document reasons for patients refusing the procedure. Data will also include complications and adverse events related to the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require alloplastic total TMJ replacement.
Not a fit: Patients with recent substance abuse issues, pregnancy, or those participating in other conflicting studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve understanding of TMJ replacement outcomes and enhance patient care.
How similar studies have performed: While there have been studies on TMJ disorders, this registry approach is relatively novel in its comprehensive data collection and focus on patient refusal.
Eligibility criteria
Show full 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
Where this trial is running
São Paulo and 22 other locations
- 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)
Study contacts
- Principal investigator: Andreas Thor, MD — Oral and Maxillofacial surgery Uppsala University Hospital
- Study coordinator: Viola Grünenfelder
- Email: viola.gruenenfelder@aofoundation.org
- Phone: +41 79 696 33 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Temporomandibular Joint Disorders, Temporomandibular joint, TMJ replacement, Trauma, Ankylosis, Degenerative joint disease, Registry