SUcceSS: SUrgery for Spinal Stenosis – A randomised, placebo-controlled trial

Not Applicable

Recruiting

• Conditions: Central lumbar spinal canal stenosis; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Surgical techniques; Neurological - Other neurological disorders

• Registration Number: ACTRN12617000884303
• Lead Sponsor: Sydney Medical School, The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified