NCT06951178

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

Unlocking TMJs Clinical Study: Safety and Performance of Materialise's Patient-specific TMJ System

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Materialise · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement. The study will evaluate the efficiency, safety, clinical performance, accuracy, benefits, and risks associated with long-term use and the impact on life quality and diet of the TMJ system, its fixation devices, TMJ Implant trial, and guides in the adolescent and adult populations.

Detailed description

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.

Conditions

• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
DEVICE	TMJ Total Arthroplasty System (TMJ System)	All patients treated or to be treated with the TMJ Total Arthroplasty System for TMJ reconstruction. The TMJ Total Arthroplasty System (TMJ System) is a medical device intended to restore the TMJ. It comprises two articulating components: a temporal component and a mandibular component. The TMJ System is patient-specific based on the patient's anatomy and surgical treatment. Different shape designs are possible depending on the patient's anatomy and the type of surgery performed.

Timeline

• Start date: 2025-06-01
• Primary completion: 2037-06-01
• Completion: 2037-06-01
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: Denmark