Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study.
Andreas Thor, Martin Bengtsson, Krzysztof Dowgierd...
https://pubmed.ncbi.nlm.nih.gov/41802784Actively Recruiting
Led by AO Innovation Translation Center · Updated on 2026-02-18
200
Participants Needed
23
Research Sites
65 weeks
Total Duration
Researchers are collecting prospective data from about 200 patients who receive alloplastic total temporomandibular joint (TMJ) replacements. This registry aims to understand the clinical reasons for TMJ replacement, treatment patterns across regions, patient outcomes including pain, jaw movement, and quality of life, as well as reasons why some patients refuse this surgery. The study is observational and does not assign specific treatments but records routine care provided by individual clinicians. Patients undergoing TMJ replacement will be followed for up to 5 years after their surgery, with assessments at multiple time points including 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months. Data collected include treatment details, clinical evaluations such as mandibular movements and occlusal status, patient-reported outcomes like pain and diet limitations, as well as radiological parameters and any complications that occur. Cases of patients who refuse the TMJ replacement will also be registered. Participants will be monitored through pre-operative and post-operative assessments covering functional outcomes, quality of life questionnaires, and imaging studies. Researchers will track adverse events, survival, and other clinical factors over the five-year period. The registry collects detailed data on demographics, comorbidities, and treatment outcomes to explore predictors of favorable results and improve understanding of TMJ replacement effects.
CONDITIONS
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days or until discharge
Participants undergo alloplastic total temporomandibular joint (TMJ) replacement surgery and receive immediate post-operative care as part of routine clinical treatment.
Visits around the surgery and during immediate recovery
Duration - Up to 60 months after surgery
Participants are followed to assess clinical and functional outcomes, quality of life, and potential complications after TMJ replacement surgery.
Visits at 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months post-surgery
Total: 23 locations
1
Hospital BP - A Beneficência Portuguesa de São Paulo
São Paulo, Brazil
Actively Recruiting
2
Estetica Maxilofacial
Bogotá, Colombia
Suspended
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Hannover Medical School
Hanover, Germany, 30625
Actively Recruiting
5
University Hospital Leipzig
Leipzig, Germany
Actively Recruiting
6
Klinikum der Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Not Yet Recruiting
7
Klinikum der LMU München
Munich, Germany, 80337
Actively Recruiting
8
Sri Shankara Cancer Hospital and Research Center
Bangalore, India
Actively Recruiting
9
All India Institute of Medical Sciences (AIIMS)
New Delhi, India, 110029
Terminated
10
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3075
Actively Recruiting
11
Waikato DHB
Christchurch, New Zealand
Terminated
12
Hutt Hospital
Lower Hutt, New Zealand
Suspended
13
Mayo Hospital
Lahore, Pakistan
Terminated
14
Wojewódzki Specjalistyczny Szpital Dziecięcy
Olsztyn, Poland
Actively Recruiting
15
National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
Moscow, Russia
Actively Recruiting
16
Clinic for Maxillofacial Surgery, University of Belgrade
Belgrade, Serbia
Actively Recruiting
17
King Edward VIII Hospital
Durban, South Africa, 4030
Actively Recruiting
18
12 de Octubre University Hospital
Madrid, Spain, 28041
Actively Recruiting
19
Falu Hospital
Falun, Sweden, 79182
Actively Recruiting
20
Skåne University Hospital
Lund, Sweden
Actively Recruiting
21
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
22
Uppsala University Hospital
Uppsala, Sweden, SE-75185
Actively Recruiting
23
Universitätsspital Basel
Basel, Switzerland
Actively Recruiting
V
Viola Grünenfelder
A
Aleksandra Hodor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Andreas Thor, Martin Bengtsson, Krzysztof Dowgierd...
https://pubmed.ncbi.nlm.nih.gov/41802784