The purpose of this study is to compare two different surgical techniques for treating degenerative lumbar canal stenosis, a condition where the lower spinal canal narrows and puts pressure on the spinal nerves. For patients who continue to experience significant back and leg pain after at least three months of non-surgical treatments, surgery is often recommended to relieve the pressure.
Currently, there is an ongoing debate among spine surgeons regarding the most effective surgical approach. This study will evaluate and compare the outcomes of two established methods:
1. Segmental Decompression Alone: A procedure focused purely on removing the bone and tissue that is pressing on the spinal nerves. 2. Wide Decompression with Fixation: A more extensive removal of compressive structures, combined with adding spinal hardware (pedicle screws and rods) to stabilize the spine.
Researchers will observe 56 patients over an 18-month period. The primary goal is to determine if one technique offers better functional recovery and pain relief than the other. Researchers will measure success by tracking changes in patients' daily physical function (using the Oswestry Disability Index), reductions in lower back and leg pain, improvements in walking distance, and the time it takes to perform the surgery.
Eligible participants are adult males and females over the age of 40 with symptomatic multilevel stenosis, provided their dynamic x-rays do not show existing spinal instability.
Age greater than 40 years
Both males and females
Multilevel lumbar canal stenosis with failed routine conservative treatment at least 3 months
X-ray dynamic views of the lumbar spine showing no evidence of instability
Age less than 40 years
Recurrent cases and screw revision cases
Degenerative scoliosis
Parallel
Segmental Decompression
Procedure/SurgeryA surgical technique involving the targeted removal of compressive structures in the lumbar spine to relieve neurogenic claudication and leg pain, performed without the addition of spinal instrumentation or fusion.
Wide Decompression with Fixation
Procedure/SurgeryA surgical technique that combines extensive decompression of the lumbar canal with spinal instrumentation. This involves the application of pedicle screws and rods across varying segment lengths to provide stabilization to the affected spine.
Functional Recovery as Assessed by the Oswestry Disability Index (ODI)
Functional disability will be quantified using the Oswestry Disability Index (ODI) questionnaire. The ODI is a validated index scored from 0 to 100, where 0 indicates no disability and 100 indicates maximum possible disability. A decrease in the score from baseline indicates functional improvement and a better surgical outcome.
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This trial is not recruiting at the moment. You can still explore other options:
