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

Launched by MATERIALISE · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a specific system called the Materialise TMJ Total Arthroplasty System, which is used to replace the temporomandibular joint (TMJ) in patients with TMJ disorders. The goal is to understand how well this system works over time, how safe it is, and how it impacts patients' quality of life and ability to eat. The study will look at both past and present patients over a period of ten years to gather comprehensive information.

To be eligible for this study, participants must be patients who have been prescribed the Materialise TMJ Total Arthroplasty System. They also need to understand the study details and sign a consent form. However, those with known allergies to certain metals, insufficient bone quality for the implant, active infections, or certain other conditions may not be able to participate. If you join the study, you can expect regular follow-ups to monitor your health and the performance of the TMJ system. This trial is currently not yet recruiting participants, so if you're interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients prescribed with Materialise TMJ Total Arthroplasty System for TMJ reconstruction
• • Patient who has received and understood the study information leaflet and has agreed to participate in the study and signed the informed consent form (ICF) (adult or legal guardian(s) if minor).
• Exclusion Criteria:
• • Known hypersensitivity to Titanium, Nickel, or Cobalt-Chrome alloys.
• • Patient conditions where there is not enough bone quality or quantity to support the components.
• • Active infection in the anatomical area or the vicinity of the site to be implanted, preventing the implantation of the device.
• • Patients with marked hyperfunctional habits (e.g., tooth clenching, bruxism).
• • Pregnant woman.
• • Patient is known to be or suspected of being unable to comply with the study protocol or proposed follow-up visits by the investigator.