Status:
NOT_YET_RECRUITING
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Lead Sponsor:
Materialise
Conditions:
Temporomandibular Joint Disorders
Eligibility:
All Genders
Brief 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....
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2037
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06951178
Start Date
June 1 2025
End Date
June 1 2037
Last Update
April 30 2025
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark, 2100