Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
ConditionTemporomandibular Joint Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMaterialise
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial population
All patients treated or to be treated with the Materialise TMJ Total Arthroplasty System for TMJ reconstruction.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
TMJ Total Arthroplasty System (TMJ System)
DeviceAll 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
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
1
Safety endpoint: Occurrence rate of periprosthetic infection
Periprosthetic infection is defined as a confirmed microbial infection involving the implanted TMJ prosthesis. After implantation, but in the long term, it could also contribute to a gradual decline in implant function over time, so a cure of the infection usually requires removal or replacement of the prosthesis. Unit of Measure: Percentage of participants (%): The occurrence rate will be calculated as the proportion of participants with at least one confirmed periprosthetic infection (numerator) divided by the total number of study participants (denominator).
Time frame
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.2
Radiological Parameter Endpoint: Presence of Ectopic Bone
The presence of ectopic bone refers to the formation of bony structures in locations where bone tissue is not typically found, including abnormal bone growth around the implant and changes in the shape or contour of surrounding bone structures. This is assessed by the investigator through radiological imaging. Additional information captured if present: Ectopic bone location: Soft tissue, Ramus, Joint space Shape/contour changes: Present, Absent Unit of Measure: Occurrence rate of ectopic bone.
Time frame
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.3
Performance Endpoint: Mean Interincisal Opening (MIO)
The inter-incisal opening is the magnitude of the aperture formed between the upper and lower incisors during maximal mouth opening. It is commonly assessed by measuring the distance between the incisal edges of the upper and lower incisors. This metric is relevant in medical and dental evaluations as it estimates the mandibular range of motion and offers diagnostic insights into various orofacial conditions, including temporomandibular joint disorders and restricted jaw mobility.The reference values for MIO can vary among individuals and depend on factors such as age, gender, and overall health. Normal ranges typically fall between 35 to 55 mm. The amount of open bite should be subtracted for the MIO measurement, and in deep bites, the amount of vertical overlap should be added to the measurement for accurate determination of MIO. A larger MIO is considered as better.
Time frame
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.4
The relationship between the device's success rate and the underlying medical condition
The relationship between the device's success rate and the underlying medical condition for up to 10 years could help in understanding how different medical conditions impact the success rate of the TMJ replacement device over time. It could highlight which conditions are associated with better or worse outcomes.
Time frame
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 conditionSponsors and contacts
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Source ClinicalTrials.gov
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