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

NCT06951178 | Not Yet Recruiting

• 1 other identifier: SMAT013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular Joint Disorders; Implant

Outcome Measures

Primary Outcomes (1)

• Implant success rate

  This metric evaluates the percentage of implanted devices that remain in place and functional over a 10-year follow-up period. It directly reflects the device's safety and long-term effectiveness. Success in durability is defined as device securely in place and functional at 10-year follow-up given implant stability \& joint function. The implant functions effectively throughout the follow-up period without major malfunctions, loosening, or breakage. Mechanical Failure is defined as reoperation with device removal related to the device implant loosening, implant fracture, repeated joint dislocation. Biological Failure is defined as reoperation with device removal related to the device periprosthetic infection, biofilm, allergic reaction to the implant materials.

  10-year follow-up post-implantation, with evaluations at Week 1, Week 4, Month 3, Month 6, Year 1, Year 2, Year 3, Year 5, and Year 10, or until device removal.

Secondary Outcomes (32)

• Safety endpoint: Occurrence rate of periprosthetic infection

  From implantation up to 10-year follow-up, with evaluations at Week 1, Week 4, Month 3, Month 6, Year 1, Year 2, Year 3, Year 5, and Year 10, or until device removal or re-intervention due to implant-related or non-implant-related complications.

• Radiological Parameter Endpoint: Presence of Ectopic Bone

  From implantation through 10-year follow-up, with (CB)CT scans performed at Week 1, Week 4, Year 1, Year 3, Year 5, and Year 10, or until device removal.

• Performance Endpoint: Mean Interincisal Opening (MIO)

  From baseline (pre-implantation) through 10-year follow-up post-implantation, with evaluations at baseline, discharge, Week 1, Week 4, Month 3, Month 6, Year 1, Year 2, Year 3, Year 5, and Year 10, or until device removal.

• The relationship between the device's success rate and the underlying medical condition

  Up to 10-year follow-up post-implantation, with evaluations at Week 1, Week 4, Month 3, Month 6, Year 1, Year 2, Year 3, Year 5, and Year 10, or until device removal due to mechanical or biological failure, stratified by underlying medical condition

• Mean implantation time

  From implantation until device removal or up to 10-year follow-up post-implantation.

Interventions

TMJ Total Arthroplasty System (TMJ System) DEVICE

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.

Also known as: Temporomandibular joint reconstruction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated or to be treated with the Materialise TMJ Total Arthroplasty System for TMJ reconstruction.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materialise: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Dorien Haesen, PhD

CONTACT

+32 11 28 69 48; dorien.haesen@archerresearch.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2037
• Study Completion (Estimated): June 1, 2037
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)