Large-Scale Evaluation of a Clinical Decision Tree for the Management of Low-Energy Thoracic and Lumbar Vertebral Compression Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Evaluate the clinical and radiological healing outcomes of patients managed according to a clinical decision tree for one or more low-energy vertebral compression fractures (LEVCFs)
研究概览
简要总结
Percutaneous vertebroplasty is widely used for low-energy vertebral compression fractures, but its clinical benefits remain debated. Studies and meta-analyses have reported mixed results, while complications occur in a significant proportion of patients, highlighting the importance of careful patient selection. To standardize management, a clinical decision tree was developed based on patient age, MRI findings, pain severity (VAS), and radiological deformity.
详细描述
Percutaneous vertebroplasty was first described in France in 1987 . Since its introduction, this minimally invasive technique has become widely accepted and is now a routine treatment for low-energy vertebral compression fractures (LEVCFs), also referred to as vertebral "crush" fractures. Clinical outcomes, including pain relief, analgesic consumption, and quality of life assessed through self-administered questionnaires, are commonly used to evaluate the effectiveness of the procedure.
Over the past 20 years, several randomized controlled trials (RCTs) have been conducted to assess the efficacy of vertebroplasty compared with non-surgical management (including bracing and placebo treatment). Two recent meta-analyses identified 13 RCTs published by January 2019 and 14 RCTs by July 2020, reaching different conclusions.
In 2019, Lou et al. concluded that percutaneous vertebroplasty was effective and safe only in patients with acute low-energy vertebral compression fractures associated with persistent and severe pain. In contrast, Lainez Ramos-Bossini et al. concluded in 2020 that vertebroplasty offered significant benefits compared with non-surgical treatment, including short-term pain relief and improved quality of life. However, these benefits appeared more limited when vertebroplasty was compared with placebo treatment.
The conclusion of the Cochrane review published by Buchbinder et al. in 2018 remains relevant today: "Based on high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty in the routine management of acute or subacute osteoporotic vertebral fractures." .
Furthermore, recent studies involving large patient cohorts have reported a significant rate of complications associated with percutaneous vertebroplasty. Among 1,932 patients, 166 (8.6%) experienced a complication, including 53 minor complications (2.7%) and 95 major complications (4.9%) . Patient selection appears to play a crucial role in the occurrence of complications, as suggested by Scheyerer et al. in a recent literature review .
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years
- •One or more low-energy vertebral compression fractures (LEVCFs) confirmed by MRI
- •Fractures located between T7 and L5
- •Compression fractures classified as A1.1, A1.2, or A1.3 according to the Magerl classification [15]
- •Management in accordance with the clinical decision tree
- •Vertebroplasty performed by an interventional radiologist, orthopedic surgeon, or neurosurgeon
- •Vertebral augmentation performed by an orthopedic surgeon or neurosurgeon, with or without navigation assistance
- •Conservative treatment consisting of a lumbar brace worn during daytime, with duration individualized according to the patient's needs, and physiotherapy initiated between 45 and 90 days after treatment, including core stabilization, stretching, and strengthening of the posterior muscle chain and abdominal muscles, based on active rehabilitation rather than manual therapy (no massage therapy).
排除标准
- •Pregnant or breastfeeding women
- •Individuals under administrative or judicial supervision
- •Age < 50 years or > 90 years
- •Pathological vertebral fracture
- •Presence of other osteoporotic fractures during the study follow-up period (6 months)
- •Non-compliance with the clinical decision tree
- •Dementia or cognitive impairment preventing data collection at the final follow-up (telephone interview), assessed using the Mini-Cog test (score < 3 = exclusion)
- •Refusal to participate during the telephone interview or inability to provide non-opposition (e.g., under legal guardianship)
结局指标
主要结局
Evaluate the clinical and radiological healing outcomes of patients managed according to a clinical decision tree for one or more low-energy vertebral compression fractures (LEVCFs)
时间窗: 1 year
Radiological fracture healing, assessed on standard radiographs based on cortical continuity, disappearance of fracture lines, absence of progressive kyphosis, and absence of osteosynthesis hardware-related complications. Fracture healing will be classified as complete, partial, or absent.
次要结局
- Assessment of vertebroplasty cement filling quality(1 year)
- Assessment of clinical outcomes(1 year)
- Assessment of radiological deformity.(1 year)
- Assessment of fracture healing and associated factors(1 year)
- Assessment of complications(1 year)
- Assessment of treatment timelines(1 year)