Long-term Safety and Performance of Materialise's Patient-specific TMJ System.

The study begins with patient inclusion and pre-operative examination, where eligibility is assessed based on inclusion and exclusion criteria. Informed consent is obtained, and if a participant drops out before implantation, a new patient is enrolled. Pre-operative assessments include (CB)CT imaging, collection of demographic details, medical history, and co-morbidities using the Charlson Comorbidity Index (CCI). Other pre-operative evaluations include maximal inter-incisal opening (MIO), occlusion, diet consistency, and several questionnaires to assess quality of life, jaw function, and speech. Pre-operative (CB)CT scans are used for surgical planning and device design.

During surgery and hospital stay, the index procedure marks the patient's enrollment. Surgical details are documented, including the approach, device characteristics, operation time, and complications. Intraoperative adverse events, such as allergic reactions or hematoma, are recorded. A post-operative (CB)CT scan is performed within a week, and patient and surgeon satisfaction, both functional and aesthetic, are recorded. Any post-operative complications are tracked.

For follow-up, the study includes 9 follow-up visits at intervals of 1 week, 4 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years, and 10 years. At each visit, MIO, occlusion, diet consistency, and jaw function are assessed, and patients complete the EQ-5D-5L, OHIP-14, and Helkimo Clinical Dysfunction Index questionnaires. A (CB)CT scan is performed at specific follow-ups, and any post-operative complications, adverse events, or re-interventions are reported. Medication intake is recorded as well.