None listed
Conditions
Brief summary
Surgical decompression for symptomatic spinal stenosis is justified primarily upon clinical experience, expert consensus and pathophysiological considerations, not high quality clinical trials – results of past research have been significantly confounded by placebo effects of surgery. There is an urgent need to rigorously test decompressive surgery for spinal stenosis as the intervention is expensive and potentially harmful and is increasingly used reflecting our ageing community. The efficacy of surgical decompression, the most popular procedure for spinal stenosis, has not yet been proven, as it has never gone through high level of scientific scrutiny to establish its efficacy or safety beyond placebo effects. The SUcceSS trial aims to randomly allocate 160 participants with chronic, symptomatic lumbar spinal stenosis to either decompressive surgery or placebo surgery to measure the efficacy of decompressive surgery on patients' outcomes with central spinal canal stenosis.
Interventions
a) Decompressive spinal surgery via laminectomy (which involves the removal of the lamina and spinous process of the vertebrae at the affected level with a high speed drill and/or bone punch, to relieve the pressure on the spinal nerve) or laminotomy (a small opening of the lamina above and below the spinal nerve is created with the high speed drill, leaving the remaining structure of the lamina intact) versus placebo surgery (same incision and muscle dissection as the active intervention but wi
a) Decompressive spinal surgery via laminectomy (which involves the removal of the lamina and spinous process of the vertebrae at the affected level with a high speed drill and/or bone punch, to relieve the pressure on the spinal nerve) or laminotomy (a small opening of the lamina above and below the spinal nerve is created with the high speed drill, leaving the remaining structure of the lamina intact) versus placebo surgery (same incision and muscle dissection as the active intervention but without bone removal). b) The use of the surgical procedures of laminotomy or laminectomy will be as per the surgeons standard procedures and will reflect real world practise. c) Spinal surgery will be performed in the operating theatres of the participating institutions and the operating time will vary from 2 to 4 hours d) Registered medical practitioners with no regulatory impediment to perform spinal decompression surgery in Australia will be invited to participate as study doctors
Sponsors
Sydney Medical School, The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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; 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.
Outcome results
None listed