Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty, Stentoplasty and Kyphoplasty Versus Thermal Facet Ablation.

Szeged University1 个研究点分布在 1 个国家目标入组 1,000 人开始时间: 2020年12月15日最近更新: 2026年5月26日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 1,000
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Study design: A prospective randomized study is performed and cases are selected where the indication for surgery is a vertebral compression fracture.

Object: To assess outcomes and complications in patients undergoing vertebroplasty, kyphoplasty and thermal facet ablation for vertebral compression.

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

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

•Age >18 years-old
•Subjects who are able to give informed consent and to understand and comply with study requirements.
•Predominantly axial back and low back pain ≥ 1 month in duration with no radicular pain below the knee that failed to conservative therapy.
•Subjects who have chronic back pain attributed to vertebral compression fractures (AO Spine A1 or A2 fractures) based on clinical evaluation (CT or MRI).

排除标准

•Subjects who decline to provide written consent or follow-up.
•Subjects who are pregnant.
•Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
•Subjects who have an active systemic or local infection.
•Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
•Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)
•Psychopathology including depression, somatization or poor coping skills
•Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI > 35kg/m2).
•History of previous Radiofrequency Ablation at the same level(s) in the previous 12 months.
•History of previous Vertebroplasty at the same level(s) in the previous 12 months.

研究者

发起方

Szeged University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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