Unlocking TMJs Clinical Study: Safety and Performance of Materialise's Patient-specific TMJ System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Materialise
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implant success rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Implant success rate
时间窗: 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.
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.
次要结局
- Safety endpoint: Occurrence rate of marginal mandibular palsy(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.)
- 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.)
- Surgical operation time(At procedure (intraoperative).)
- Total hospital post-operative stay(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.)
- Perioperative complications(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.)
- Intraoperative blood loss (mL)(At procedure (intraoperative))
- Technical success of the implantation(At procedure (intraoperative), and at first post-operative imaging (CB)CT at Week 1 for comparison with the pre-operative plan.)
- Radiological Parameter Endpoint: Displacement of Ramus Component(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.)
- Safety endpoint: Occurrence rate of weakness of the temporal branch of the facial nerve(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.)
- Safety endpoint: Occurrence rate of total facial palsy(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.)
- Safety endpoint: Occurrence rate of other sensory changes (lip, tongue, auriculotemporal nerve)(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.)
- Safety endpoint: Occurrence rate of other general post-operative complications(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.)
- Safety endpoint: Occurrence rate of stable implant components(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.)
- Safety endpoint: Re-intervention rate up to 10 years follow-up, implant-related or not.(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.)
- Performance Endpoint: Occlusion(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.)
- Performance Endpoint: Dentition(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.)
- Performance Endpoint: Diet Consistency Evaluation Numerical Rating Scale (NRS)(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.)
- Performance Endpoint: Speech Numerical Rating Scale (NRS)(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.)
- Performance Endpoint: Jaw Function Numerical Rating Scale (NRS)(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.)
- Performance Endpoint: Oral Health Impact Profile-14 (OHIP-14)(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.)
- Performance Endpoint: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)(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.)
- Performance Endpoint: Helkimo Clinical Dysfunction Index(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.)
- Performance Endpoint: Patient Satisfaction Numeric Rating Scale (NRS) - Functional and Aesthetic(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.)
- Performance Endpoint: Surgeon Satisfaction Numeric Rating Scale (NRS) - Functional and Morphological/Aesthetic(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.)
- Radiological Parameter Endpoint: Fracture of Ramus Component(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.)
- Radiological Parameter Endpoint: Screw Loosening(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.)
- Radiological Parameter Endpoint: Bone Resorption or Osteolysis Around the Implant(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.)
- Radiological Parameter Endpoint: Status of Bone Grafts (if used)(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.)