An interventional study of Segmental Decompression and Wide Decompression with Fixation in Degenerative Lumbar Spinal Stenosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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:
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.
Lumbar spinal canal stenosis secondary to degenerative disease is a common condition associated with the aging process that may ultimately lead to the compression of neural elements within the lumbar canal. The degenerative process is often a response to hypermobility and can contribute to spinal instability. While conservative treatment is generally regarded as the first-line approach, surgical decompression is indicated for symptom alleviation in patients whose symptoms persist despite adequate nonoperative management. The primary objective of surgery for lumbar stenosis is the relief of neurogenic claudication, followed by an improvement in walking capacity and a reduction of leg pain.
Over the past two decades, spinal surgeons have become increasingly familiar with instrumentation techniques, leading to a marked rise in the use of pedicle screws and rods for the treatment of degenerative lumbar stenosis. However, attention has recently shifted toward reassessing the routine use of these fusion procedures. A sustained debate continues among experts regarding the optimal surgical management, aiming to better define the indications for fusion and avoid its unnecessary application. This study aims to provide emerging evidence to help establish clearer conclusions by evaluating whether segmental decompression alone or wide decompression with fixation offers superior clinical and radiological advantages for selected patient groups.
The trial will be conducted across the Neurosurgery departments of Assiut University Hospitals and Misr University Teaching Hospital. Patient data will be collected using standardized, coded case report forms to ensure confidentiality.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 56 is below the median of 68 across 122 interventional studies indexed under Sciatica.
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Exclusion Criteria:
Participants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.
Procedure: Segmental Decompression
Participants in this arm will undergo wide surgical decompression combined with spinal fixation utilizing pedicle screws and rods for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.
Procedure: Wide Decompression with Fixation
A 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.
A 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.
Time frame: Baseline, 3 months, 6 months, and 12 months postoperative
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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