Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - 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
- 500
- 试验地点
- 12
- 主要终点
- Alleviation of Pain
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 Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.
TEKNIMED bone cements are legacy products, some marketed for more than 10 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:
- Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures, due to their efficiency and safety
- These mini-invasive procedures, where bone cement is injected into a partially collapsed vertebral body, are used to reduce pain and to provide mechanical stability
- In most patients, a rapid pain relief and an increase in mobility and quality of life are obtained
- Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare
- The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone, particularly in osteoporotic patients.
TEKNIMED has developed several bone cements currently used in vertebroplasty and kyphoplasty procedures in the treatment of vertebral weakness. Among those, one cement is also used in pedicle screw augmentation procedures.
With the increasing use of these procedures, there is a need of real-life safety and efficacy data on the bone cements.
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED spine bone cements 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 Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study
- •o For prospective inclusion:
- •Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
- •o For retrospective inclusion:
- •Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 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 or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
排除标准
- •Patients presenting one of the following conditions will not be included (contraindications per IFU):
- •Procedures other than those stated in the INDICATIONS section
- •Coagulation disorders, or severe cardiopulmonary disease
- •Unstable vertebral fractures
- •Compromise of the vertebral body or of the pedicle walls
- •Hypersensitivity or allergy to one of the constituents of the product
- •Patient clearly improving on more conservative treatment
- •Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture
- •Paediatric patients and pregnant or breast-feeding women.
结局指标
主要结局
Alleviation of Pain
时间窗: 24 months
Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits
次要结局
- Patient satisfaction(24 months)
- Antalgic Consumption(24 months)
- Restoration of quality of life(24 months)
- Stabilization of vertebrae(24 months)
- Adverse events(10 years)