Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Clinical outcome measured with the Oswestry Disability Index
研究概览
简要总结
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
详细描述
This clinical study is a regulatory Post Market Clinical Follow-Up (PMCF) measure and is aiming to collect clinical data on the performance and safety of the TSPACE® 3D implants. It is designed as a prospective, randomized, single-blind, non-interventional study in order to gain clinical data within the routine clinical application of the investigational device.
The study shall answer the question if there are detectable differences between the established titanium coated Polyether Ether Ketone (PEEK) cages of the manufacturer and the new 3D printed cages. Differences shall be observed in terms of clinical outcome, quality of life, patient satisfaction, radiological outcome and occurrence of Adverse Events / Serious Adverse Events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use
- •Written informed consent for the documentation of clinical and radiological results
- •Willingness and mental ability to participate at the follow-up examinations
排除标准
- •Patient is not willing or able to participate at the follow-up examination
- •Patient age < 18 years and >80 years
- •Patient is pregnant
- •Previous instrumented lumbar spine surgery
结局指标
主要结局
Clinical outcome measured with the Oswestry Disability Index
时间窗: 1 year postoperatively
The Oswestry Disability Index is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
- Clinical improvement: pain(preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively)
- Radiological outcome: Fusion(1 year postoperatively)
- Development of Clinical outcome measured with the Oswestry Disability Index(preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively.)
- Development Quality of life (EQ-5D-5L)(preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively)
- Radiological outcome: Implant subsidence(1 year postoperatively)
- Radiological outcome: Implant migration(1 year postoperatively)
- Rate of (Serious) adverse events(throughout the studies duration up to five years postoperatively)