Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery: Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.
研究概览
简要总结
A retrospective, single-tertiary centre observational study.
The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included.
The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.
详细描述
In the first stage of the investigation, the clinical safety and efficacy of BonAlive® putty are assessed in a retrospective case-series, and the observations are compared to the existing literature. Thereafter, a retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and AB to AB alone for clinical safety and efficacy. The cases will be matched up with the controls by gender, age, smoking behavior, the number of operated levels and the site of operated levels as far as possible. The chosen surgical technique will be the most commonly used.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 接受健康志愿者
- 否
入选标准
- •Performed spine fusion operation
- •BonAlive® putty used in the operation
排除标准
- •Age under 18
- •Use of other synthetic bone graft substitute or expander materials than BonAlive® putty in the operation
- •Less time than two years since the index operation and no CT-proof of intended bony fusion
结局指标
主要结局
15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.
时间窗: 24 months
Health index on a 0-1 scale has been used successfully in several pharmacoeconomic evaluations. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.
时间窗: 24 months
Radiologic endpoints are based on a neuroradiologist evaluatyion possible complications (breakage and/or loosening of the instrumentation) and bony fusion on a modified Bridwell grading criteria I-IV for PLF.
Clinical outcomes are for pain VAS:
时间窗: 24 months
Visual analogue scale 1-10.
EQ-5D cost effectiviness questionnaires.
时间窗: 24 months
Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation.
ODI: (Oswestry Low Back Pain Disability Questionnaire).
时间窗: 24 months
ODI is validated to use in patients with low back pain.The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
次要结局
- To demonstrate that the clinical efficacy of BonAlive® putty used together with autologous bone in spine fusion operations is not inferior to the clinical efficacy of autologous bone used alone.(24 months)
- To demonstrate that the clinical use of BonAlive® putty does not cause excess infections or other complications subsequent to spine fusion operations compared to the reported amounts in the literature without the use of BonAlive® putty.(24 months)