Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in health-related quality of life measured using the EQ-5D-5L index score
研究概览
简要总结
This study is designed to determine whether sacroplasty, a minimally invasive procedure to stabilize sacral fractures, improves quality of life and functional recovery in adults aged 50 years or older with sacral or posterior pelvic fragility fractures. These fractures are common in older adults and can cause prolonged pain, reduced mobility, and an increased rate of mortality and risk of complications such as pneumonia, blood clots and pressure sores. Standard treatment usually involves pain management, physiotherapy and mobilization but recovery can be slow.
Participants will be randomly assigned to receive either sacroplasty under local anaesthetic (with optional sedation) performed by interventional radiologists or standard non-surgical care including analgesia and physiotherapy. Follow-up assessments will take place at 6 weeks and 6 months to evaluate pain, mobility, healthcare use, safety and overall quality of life.
The goal of the study is to provide evidence on whether sacroplasty can accelerate recovery, reduce complications and improve independence and quality of life in older adults with these fractures.
详细描述
Sacral insufficiency fractures are common in the elderly population. These fractures are typically managed with conservative management, including analgesia, physiotherapy and mobilisation. However, conservative treatment is often complicated by prolonged pain, immobility, prolonged hospitalisation and loss of independence. There is also a high risk of medical complications associated with deconditioning, such as atelectasis, pneumonia, pressure sores and venous thromboembolism. The mortality rate after sacral insufficiency fractures is up to 17.5% at 1 year and 25.5% at 3 years. Sacroplasty, a minimally invasive percutaneous cement augmentation procedure for sacral fractures, may offer rapid pain relief and earlier mobilisation. Some studies have shown an improvement in pain scores and early return to mobility following sacroplasty but larger, higher quality studies are needed.
This study investigates the effectiveness of sacroplasty, a minimally invasive percutaneous cement augmentation procedure, in improving outcomes for patients with sacral insufficiency fractures.
This study is an open-label, parallel-group randomised controlled trial designed to compare sacroplasty with standard conservative management. The intervention will be performed under local anaesthesia with optional conscious sedation, in contrast to the ASSERT trial which performed sacroplasty under general anaesthesia. This approach has been chosen to improve feasibility and recruitment by enabling inclusion of a broader and potentially frailer patient population who may not be suitable for general anaesthesia,
The primary objective is to determine whether sacroplasty improves health-related quality of life and functional recovery compared with standard care. Secondary objectives include evaluation of pain, mobility, healthcare utilisation and safety outcomes.
The findings of this study are expected to provide important evidence to inform clinical practice and improve the management of sacral insufficiency fractures in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Blinding is not feasible due to the invasive nature of sacroplasty.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or older
- •Low-energy sacral or posterior pelvic fracture confirmed on CT
- •Symptom duration ≤6 weeks with ongoing pain ≥48 hours
- •Suitable for sacroplasty under local anesthetic with optional sedation
- •Informed consent
排除标准
- •High-energy or unstable pelvic ring fracture requiring open fixation
- •Active infection or malignancy at fracture site
- •Uncorrectable coagulopathy or anatomy precluding safe sacroplasty
- •Life expectancy <3 months
- •Participation in conflicting interventional trial
- •Previous sacroplasty
- •Patient not suitable for sacroplasty under local anesthetic with optional sedation
研究组 & 干预措施
Sacroplasty
Participants in this arm will undergo percutaneous sacroplasty under local anesthesia, with optional conscious sedation. The procedure will be performed by interventional radiologists to stabilize sacral or posterior pelvic fragility fractures. Participants will be followed up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.
干预措施: Percutaneous Sacroplasty (Procedure)
Standard conservative management
Participants in this arm will receive non-surgical management, including analgesia, mobilization, and physiotherapy according to local protocols. Participants will be followed up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.
干预措施: Standard conservative management (Other)
结局指标
主要结局
Change in health-related quality of life measured using the EQ-5D-5L index score
时间窗: Baseline, 2 weeks, 6 weeks, 3 months, 6 months
Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) index score. The EQ-5D-5L assesses five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The index score typically ranges from values below 0 (health states worse than death) to 1 (perfect health), with higher scores indicating better health-related quality of life.
次要结局
- All-Cause Mortality(30 days, 90 days and 12 months after randomization)
- Change in pain intensity measured using a Visual Analogue Scale (VAS) score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months)
- Change in mobility measured using the EQ-5D mobility dimension(Baseline, 2 weeks, 6 weeks, 3 months, 6 months)
- Length of Hospital Stay(Length of stay for index hospitalisation, measured from admission to discharge, with follow-up limited to 6 months.)
- Number of participants readmitted to hospital(Within 6 months after discharge)
- Procedural Complications(Within 30 days after the procedure)