Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
- 试验地点
- 26
- 主要终点
- Infection Rate
研究概览
简要总结
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (up to 24-months) of study participants.
详细描述
Stryker's PEEK Customized Implants are patient-specific implants based on CT-data of the individual patient and input of the surgeon. The implants are fabricated from Polyetheretherketone (PEEK) and intended to be used to fill bony voids in the cranial and craniofacial region (e.g. cranium, orbital rim, zygoma, and adjacent bone). This observational post-market clinical follow-up (PMCF) is designed to confirm the safety, performance and clinical benefit of Stryker's PEEK Customized Implants for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH). Infection of implants is one of the common risks associated with this type of surgery. This PMCF study will investigate infection rate as the primary safety endpoint. These data will be collected in a real world setting, where all treatment is per routine clinical practice. The study is designed as a prospective, multi-center trial at participating institutions in the United States and in Europe. Up to 110 study participants will be enrolled in this PMCF. Stryker's PEEK Customized Implants are intended to stay implanted permanently. Therefore, study participants will be followed for up to 24-months after implantation of the devices to allow evaluation of long-term safety and performance of the products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 42 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is eligible for a PEEK customized implant as per routine clinical practice.
- •Subject is 12 years of age or older (Europe only).
- •Subject is 3.5 years of age or older (USA only).
- •Adult subjects able to give consent.
- •Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent.
- •Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf.
排除标准
- •Subject has an active systemic or local infection.
- •Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies.
- •Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant.
- •Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care.
- •Knowingly pregnant or nursing women.
- •Concomitant participation in other clinical trials related to cranioplasty.
- •Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.
结局指标
主要结局
Infection Rate
时间窗: 24 months post-operative
Assessment of rate of infection associated with Stryker's PEEK Customized Implants.
次要结局
- Length of hospitalisation(Up to 1 month)
- Persistent temporal hollowing(24 months post-operative)
- Ability to place the Customized Implant during surgery leading to good aesthetic outcome(24 months post-operative)
- Quality of life questionnaire(24 months post-operative)
- Scale of brain injuries(24 months post-operative)
- Neurological Assessment(24 months post-operative)
- Aesthetic assessment(24 months post-operative)
- Rate of implant failure(24 months post-operative)
- Incidence of device related serious adverse events (SAEs)(24 months post-operative)