Clinical trial NCT06951178: Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Official title: Unlocking TMJs Clinical Study: Safety and Performance of Materialise's Patient-specific TMJ System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Joint Disorders
Implant
Lead sponsor: Materialise
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated or to be treated with the Materialise TMJ Total Arthroplasty System for TMJ reconstruction.

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.

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.

Primary outcomes:
measure: Implant success rate
timeFrame: 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:
measure: Safety endpoint: Occurrence rate of periprosthetic infection
timeFrame: 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.
measure: Radiological Parameter Endpoint: Presence of Ectopic Bone
timeFrame: 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.
measure: Performance Endpoint: Mean Interincisal Opening (MIO)
timeFrame: 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.
measure: The relationship between the device's success rate and the underlying medical condition
timeFrame: 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
measure: Mean implantation time
timeFrame: From implantation until device removal or up to 10-year follow-up post-implantation.
measure: Surgical operation time
timeFrame: At procedure (intraoperative).
measure: Total hospital post-operative stay
timeFrame: From surgery completion untill discharge date, when the patient is deemed clinically stable and released from hospital care, assessed up to 30 days post-operatively, with the duration varying based on underlying conditions and recovery progress.
measure: Perioperative complications
timeFrame: The perioperative period, encompassing the pre-operative (before surgery), intra-operative (during surgery), and post-operative (after surgery) phases, from patient admission for surgery until discharge home.
measure: Intraoperative blood loss (mL)
timeFrame: At procedure (intraoperative)
measure: Technical success of the implantation
timeFrame: At procedure (intraoperative), and at first post-operative imaging (CB)CT at Week 1 for comparison with the pre-operative plan.
measure: Radiological Parameter Endpoint: Displacement of Ramus Component
timeFrame: 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.
measure: Safety endpoint: Occurrence rate of weakness of the temporal branch of the facial nerve
timeFrame: 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.
measure: Safety endpoint: Occurrence rate of marginal mandibular palsy
timeFrame: 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.
measure: Safety endpoint: Occurrence rate of total facial palsy
timeFrame: 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.
measure: Safety endpoint: Occurrence rate of other sensory changes (lip, tongue, auriculotemporal nerve)
timeFrame: 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.
measure: Safety endpoint: Occurrence rate of other general post-operative complications
timeFrame: Starting after operation, 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.
measure: Safety endpoint: Occurrence rate of stable implant components
timeFrame: 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.
measure: Safety endpoint: Re-intervention rate up to 10 years follow-up, implant-related or not.
timeFrame: After 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.
measure: Performance Endpoint: Occlusion
timeFrame: 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.
measure: Performance Endpoint: Dentition
timeFrame: 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.
measure: Performance Endpoint: Diet Consistency Evaluation Numerical Rating Scale (NRS)
timeFrame: 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.
measure: Performance Endpoint: Speech Numerical Rating Scale (NRS)
timeFrame: 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.
measure: Performance Endpoint: Jaw Function Numerical Rating Scale (NRS)
timeFrame: 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.
measure: Performance Endpoint: Oral Health Impact Profile-14 (OHIP-14)
timeFrame: 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.
measure: Performance Endpoint: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: 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.
measure: Performance Endpoint: Helkimo Clinical Dysfunction Index
timeFrame: 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.
measure: Performance Endpoint: Patient Satisfaction Numeric Rating Scale (NRS) - Functional and Aesthetic
timeFrame: 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.
measure: Performance Endpoint: Surgeon Satisfaction Numeric Rating Scale (NRS) - Functional and Morphological/Aesthetic
timeFrame: 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.
measure: Radiological Parameter Endpoint: Fracture of Ramus Component
timeFrame: 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.
measure: Radiological Parameter Endpoint: Screw Loosening
timeFrame: 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.
measure: Radiological Parameter Endpoint: Bone Resorption or Osteolysis Around the Implant
timeFrame: 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.
measure: Radiological Parameter Endpoint: Status of Bone Grafts (if used)
timeFrame: 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.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capital Region of Denmark
Study officials:
References: