Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
ConditionTemporomandibular Joint Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMaterialise
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- TMJ Total Arthroplasty System (TMJ System)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov