ACTRN12617000884303
Recruiting
未知
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 sites160 target enrollmentJune 16, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sydney Medical School, The University of Sydney
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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