Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
研究概览
简要总结
The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.
详细描述
This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
- •Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
- •Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
- •Patient with a degenerative sacroiliac joint disease requested a fusion procedure;
排除标准
- •Major osteoporosis (DEXA scan > 3);
- •Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
- •Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
- •Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
- •Currently pregnant or planning pregnancy;
- •Prisoner or a ward of the state;
- •Subject no willing to participate in the study;
- •Subject not affiliated to a social security insurance.
结局指标
主要结局
Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
时间窗: 12 months
A decrease of 16 points in the ODI score at 12 months compared to the preoperative score is expected in order to demonstrate a 30% effecacy of the iFuse Bedrock technique in reducing postoperative pain.
次要结局
- Proportion of subjects with postoperative SIJ fusion failure(12 months)
- Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores(3, 6 and 12 months)
- Change in Patient's quality of life(3, 6 and 12 months)
- Impact of iFuse Bedrock technique on Pelvic Incidence(During 12 months)
- Impact of iFuse Bedrock technique on the Odontoid Hip Axis(During 12 months)
- Proportion of subjects with iFuse-3D implant-related complications(12 months)
- Incidence of any serious adverse events(During 12 months)
- Impact of iFuse Bedrock technique on Pelvic Tilt(During 12 months)
- Change from baseline in sacroiliac joint pain provocation tests.(During 12 months)
- Impact of iFuse Bedrock technique on Sacral Slope(During 12 months)
- Impact of iFuse Bedrock technique on Lumbar Lordosis(During 12 months)
- Assessment of the Oswestry Disability Index(3 and 6 months)
- Impact of iFuse Bedrock technique on Thoracic Kyphosis(During 12 months)
- Impact of iFuse Bedrock technique on the T1 pelvic angle(During 12 months)