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Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Sponsor: Materialise
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.
Official title: Unlocking TMJs Clinical Study: Safety and Performance of Materialise's Patient-specific TMJ System
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-06
Completion Date
2037-06
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark