Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST' (SPHERE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- NRS (Numerical Rating Scale)
研究概览
简要总结
This is a retrospective, single-centre, single-arm post-market observational study evaluating the safety and clinical performance of the SPHEREPLAST medical device used in balloon kyphoplasty procedures for the treatment of traumatic and osteoporotic vertebral compression fractures (VCFs).
SPHEREPLAST is a titanium alloy (Ti6Al4V-ELI) trabecular sphere system designed to stabilise the vertebral body structure after balloon kyphoplasty, providing immediate mechanical stability and promoting bone ingrowth.
The study includes 40 adult patients who have been treated with SPHEREPLAST for thoracolumbar VCFs (A1, A3, OF2, OF3). Data will be collected retrospectively from medical records at four timepoints: pre-operative (baseline), within five days after surgery, at one month, and at one year post-surgery.
The primary endpoints are the changes in pain intensity (Numerical Rating Scale, NRS) and disability (Oswestry Disability Index, ODI) between baseline and 1-year follow-up. Secondary endpoints include radiographic outcomes (kyphotic angle, wedge angle, vertebral body height) and the incidence of adverse events related to the device or the procedure.
The aim of the study is to assess the real-world clinical efficacy and safety of SPHEREPLAST as an alternative to bone cement in kyphoplasty, with specific attention to pain control, functional recovery, and vertebral stability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients treated with SPHEREPLAST for post-traumatic thoracolumbar VCFs A1 and A3, osteoporotic OF2 and OF3;
- •Complete availability of X-rays/MRI/CT scans;
- •Painful vertebral fracture with bone oedema on MRI and at least NRS >4 units;
- •At least 12 months of follow-up.
排除标准
- •VCF associated with metastatic lesions and myeloma;
- •Neurological impairment with compression of the spinal cord or nerves;
- •General contraindications to surgery.
结局指标
主要结局
NRS (Numerical Rating Scale)
时间窗: between baseline (pre-operative) and 1-year follow-up
ODI (Oswestry Disability Index)
时间窗: between baseline (pre-operative) and 1-year follow-up
次要结局
- adverse events (AEs), serious adverse events (SAEs) and adverse device events (ADEs)(postoperatively, at 1 month and at 1 year)
- NRS (Numerical Rating Scale)(baseline (pre-operative) and immediate post-operative and 1-month follow-ups)
- Kyphotic Angle (KA)(post-operative and 1-year follow-up)
- Wedge Angle (WA)(post-operative and 1-year follow-up)
- vertebral body height (VBH)(baseline, immediate post-operative and 1-year follow-up)