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

NCT ID: NCT06951178

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2037-06-30

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. 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.

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 out before implantation, a new patient is enrolled. Pre-operative assessments include (CB)CT imaging, collection of demographic details, medical history, and co-morbidities using the Charlson Comorbidity Index (CCI). Other pre-operative evaluations include maximal inter-incisal opening (MIO), occlusion, diet consistency, and several questionnaires to assess quality of life, jaw function, and speech. Pre-operative (CB)CT scans are used for surgical planning and device design.

During surgery and hospital stay, the index procedure marks the patient's enrollment. Surgical details are documented, including the approach, device characteristics, operation time, and complications. Intraoperative adverse events, such as allergic reactions or hematoma, are recorded. A post-operative (CB)CT scan is performed within a week, and patient and surgeon satisfaction, both functional and aesthetic, are recorded. Any post-operative complications are tracked.

For follow-up, the study includes 9 follow-up visits at intervals of 1 week, 4 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years, and 10 years. At each visit, MIO, occlusion, diet consistency, and jaw function are assessed, and patients complete the EQ-5D-5L, OHIP-14, and Helkimo Clinical Dysfunction Index questionnaires. A (CB)CT scan is performed at specific follow-ups, and any post-operative complications, adverse events, or re-interventions are reported. Medication intake is recorded as well.

Conditions

Temporomandibular Joint Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Temporomandibular joint reconstruction

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materialise

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rigshospitalet

Copenhagen, Capital Region of Denmark, Denmark

Countries

Denmark

Central Contacts

Dorien Haesen, PhD

Role: CONTACT

dorien.haesen@archerresearch.eu

+32 11 28 69 48

Facility Contacts

Thomas Kofod, Dr.

Role: primary

tand-mund.rigshospitalet@regionh.dk

+45 35 45 20 0

Other Identifiers

SMAT013

Identifier Type: -

Identifier Source: org_study_id