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/41802784/Actively 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
V
Viola Grünenfelder
A
Aleksandra Hodor
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AO Innovation Translation Center
Lead Sponsor
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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
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/AO Innovation Translation Center
Lead Sponsor