Vertebral Augmentation versus Posterior Spinal Fusion for Severe Osteoporotic Vertebral Fractures: A Multicenter Randomized Controlled Trial (VERSUS study)

未提供0 个研究点目标入组 90 人开始时间: 2024年9月11日最近更新: 2025年1月31日

试验速览

暂无简介。

•Patients diagnosed with osteoporotic vertebral fractures (OVF) using X-ray, MRI, or CT from the date of jRCT registration until March
•Patients with OVF who visited Osaka Metropolitan University Hospital or participating institutions.
•Patients aged 65 or older at the time of consent.
•Patients with fresh OVF within 2 months of injury.
•Patients with severe low back pain (VAS >= 40).
•Patients with OVF between T10 and L2 levels.
•Patients who have poor prognostic factors with conservative treatment (e.g., cases with confined high signal intensity areas or diffused low signal intensity areas in the fractured vertebra on T2-weighted MR images, or cases with endplate injury on both sides).
•Patients with severe mobility of the fractured vertebra (vertebral motion angle >= 14 degrees) or patients with endplate injury on both sides.

•Patients who injured by high-energy trauma.
•Patients with OVF unsuitable for vertebroplasty, such as those with diffuse idiopathic skeletal hyperostosis or ankylosing spondylitis.
•Patients with stable OVF (vertebral motion angle < 14 degrees) or without endplate injury on both sides, for whom posterior fusion surgery is not indicated.
•Patients with neurological deficits due to OVF.
•Patients suspected of pathological fractures (e.g., OVF due to metastatic spinal tumors or pyogenic spondylitis).
•Patients diagnosed with dementia.
•Patients treated for psychiatric disorders, including those with strong psychosocial factors.
•Patients treated for neurological disorders such as Parkinson's disease.
•Patients seemed unsuitable for participation in the study by the primary physicians.

Oswestry Dissability Index (ODI) 24 weeks after surgery

发起方

未提供