- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542054
Segmental Decompression Versus Wide Decompression With Fixation for Degenerative Lumbar Canal Stenosis
Segmental Decompression Versus Wide Decompression With Fixation in Treatment of Degenerative Lumbar Canal Stenosis
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:
- Segmental Decompression Alone: A procedure focused purely on removing the bone and tissue that is pressing on the spinal nerves.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age less than 40 years
- Recurrent cases and screw revision cases
- Degenerative scoliosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Segmental Decompression Alone
Participants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.
|
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.
|
|
Active Comparator: Wide Decompression with Fixation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Recovery as Assessed by the Oswestry Disability Index (ODI)
Time Frame: Baseline, 3 months, 6 months, and 12 months postoperative
|
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.
|
Baseline, 3 months, 6 months, and 12 months postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lumbar: Seg. vs Wide Decomp
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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