CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Materialise
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Last visit success rate of the device after the surgical implantation of Materialise patient-specific CMF Porous Titanium Implants
研究概览
简要总结
The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0 - <12 years old), adolescent (12 - <22 years old), and adult (≥ 22 years old) populations.
详细描述
The loss of bone substance or continuity in the cranial and/or facial region can result from trauma, infection, benign or malign tumor resection, and therapeutic side effects (e.g., radiotherapy). CMF Porous Titanium Implants are patient-specific solutions matched with the patient's anatomy to reconstruct bone defects accurately. Following a premarket clinical evaluation and considering long-term risk management, the decision to conduct a retrospective post-market clinical follow-up study was based on identifying possible residual risks and uncertainty about long-term safety and clinical performance that may impact the benefit/risk ratio of the CMF porous titanium devices, thereby ensuring the continued safety and efficacy of these CMF devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients of any age are eligible for this study.
- •Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction.
- •Patients who have followed Standard of Care, as determined in each case by the treating surgeon.
排除标准
- •Known hypersensitivity to Titanium at the time of surgery.
- •Patients who had or will receive the TMJ Total Arthroplasty System.
- •Pregnancy at the time of surgery.
结局指标
主要结局
Last visit success rate of the device after the surgical implantation of Materialise patient-specific CMF Porous Titanium Implants
时间窗: Last visit (up to 8 years post-implantation)
Success is defined as follows: \- The device is securely in place and functional as of the last follow-up or until its removal for reasons unrelated to the device itself. Failure is defined as follows: * Reoperation without device removal related to the device. * Reoperation with device removal related to the device.
次要结局
- Perioperative complications related and unrelated to CMF Porous Titanium Implants(Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress)
- General post-operative complications up to standard of care (SOC) follow-up(4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up)
- Re-intervention rate, implant-related or not(Up to 8 years follow-up)
- Intraoperative blood loss (mL)(At procedure)
- Technical success of the implantation(At procedure)
- Accuracy of the device implantation compared to the pre-operative plan(4 weeks follow-up)
- Implant migration(3 months, 1 year follow-up)
- Implant time of the device(From surgery up to 8 years)
- Surgical operation time(At procedure)
- Total hospital post-operative stay(Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress)