SUcceSS: SUrgery for Spinal Stenosis – A randomised, placebo-controlled trial to measure the effect of decompressive spinal surgery versus placebo surgery on walking and function in patients with lumbar spinal stenosis.

Sydney Medical School, The University of Sydney0 个研究点目标入组 160 人开始时间: 2017年6月16日最近更新: 2024年5月21日

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 160

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 40 Years 至 o limit（—）
性别: All

入选标准

•1. Be 40 years of age or older;
•2. Present with complaints of neurogenic claudication for at least 3 months. Neurogenic claudication is defined as pain, numbness and/or fatigue below the gluteal line with or without back pain (if back pain present, leg pain is greater than back pain) that is precipitated by walking and alleviated by sitting or lumbar flexion; symptoms of neurogenic claudication may involve one or both lower limbs; and may include buttock pain in addition to lower limb symptoms;
•3. Have grades B- D stenosis as defined by Schizas (2010) indicating occlusion (absent CSF signal) of the central lumbar spinal canal at one or two levels on T2 weighted MRI or CT-Myelogram;
•4. Be considered by a study surgeon to be medically suitable for single or dual-level spinal decompression surgery;
•5. Have not improved with non-surgical treatment (e.g. physical therapy, stretching, exercises).

排除标准

•1. Under workers compensation;
•2. Serious spinal pathology including cancer, infection, cauda equina syndrome, spinal fracture, inflammatory arthritides;
•3. Present with active Paget’s disease of the spine;
•4. Previous lumbar spinal surgery at the same levels;
•5. Motor deficit related to lumbar compression (Medical Research Council (MRC) grades 0 – 4) and the motor deficit interferes with walking ability;
•6. Presence of known or demonstrated peripheral vascular disease causing vascular claudication i.e., claudication accompanied by absent foot pulse or vascular insufficiency detected with Doppler Ultrasound or CT angiography;
•7. Presence of significant lumbar scoliosis (Cobb angle >25°) or other spinal deformities;
•8. Presence of lumbar instability defined as more than 4mm or 10 degrees of angular motion (at affected or adjacent level) between flexion and extension on upright lateral radiographs (to exclude patients who might need to undergo concurrent surgical fusion);
•9. Meyerding Classification Grade 2 or greater spondylolisthesis;
•10. Symptomatic hip disease with symptoms reproduced with external or internal rotation of the hip joint;
•11. Cognitive impairment or inadequate language skills that interfere with patient’s ability to give fully informed consent, even in the presence of a third-party interpreter, or complete the baseline or follow-up assessments
•12. Participation in a concurrent clinical trial;
•13. Participant’s responsible surgeon believes it is not appropriate for participant to part take.

研究者

发起方

Sydney Medical School, The University of Sydney

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