Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Teknimed
- 入组人数
- 425
- 试验地点
- 6
- 主要终点
- Successful bone repair
研究概览
简要总结
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.
TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.
详细描述
It is admitted that:
- Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin.
- Due to their chemical composition similar to bone tissue, synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient (quantity to sample, infection of sampling site…).
- Bone substitutes are bioresorbable and replaced by bone during the healing process (bone remodelling).
- Nowadays, bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects. They are indicated and used in various pathologies and types of surgery, but they always have the same intended use: to fill a bone void.
- Bone substitutes are also used in spine surgeries for cage filling and/or posterolateral fusion.
TEKNIMED has developed several bone substitutes currently used in various types of surgery. Due to their increasing use, there is a need of real-life safety and efficacy data on these products.
This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years or older.
- •Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and
- •o For prospective inclusion:
- •Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.
- •o For retrospective inclusion:
- •Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 and the date of the site initiation visit
- •Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.
排除标准
- •Patients presenting one of the following conditions will not be included:
- •Under trusteeship or guardianship
- •Pregnancy or breast-feeding women
- •According to contraindications per IFU:
- •Procedures other than those stated in the INDICATIONS section
- •Patients susceptible to allergic reactions to the product components.
- •CERAFORM®, TRIHA+®:
- •- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))
- •Use in vertebroplasty procedures
- •Subcutaneous use
结局指标
主要结局
Successful bone repair
时间窗: 24 months
Evaluated through the rate of revision surgery due to a failure of the substitute.
次要结局
- Alleviation of Pain(24 months)
- Bone reconstruction(24 months)
- Well-being(24 months)
- Patient satisfaction(24 months)