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

NCT06951178 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Disorders

Interventions

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.

Sponsors & Collaborators

  • Materialise

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2037-06-30
Completion
2037-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951178 on ClinicalTrials.gov