Degenerative Lumbar Spinal StenosisNCT07542054
Segmental Decompression Versus Wide Decompression With Fixation for Degenerative Lumbar Canal Stenosis
A study testing Segmental Decompression and Wide Decompression with Fixation in people with Degenerative Lumbar Spinal Stenosis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Segmental Decompression and Wide Decompression with Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 40 years
- Recurrent cases and screw revision cases
- Degenerative scoliosis
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Segmental Decompression, Wide Decompression with Fixation
- Keywords
- Lumbar Canal Stenosis, Degenerative Spine Disease, Neurogenic Claudication, Sciatica, Low Back Pain, Segmental Decompression, Wide Decompression
- Medical subject headings
- Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental DecompressionProcedure or surgery
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.
Wide Decompression with FixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Segmental Decompression Alone | Active comparator | Participants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis. Receives: Procedure: Segmental Decompression |
| Wide Decompression with Fixation | Active comparator | 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. Receives: Procedure: Wide Decompression with Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ebrahim Hussein Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542054
- Sponsor's protocol ID
- Lumbar: Seg. vs Wide Decomp
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Decompression Versus Wide Decompression With Fixation in Treatment of Degenerative Lumbar Canal Stenosis
- ClinicalTrials.gov ID
- NCT07542054
- Acronym / sponsor ID
- Lumbar: Seg. vs Wide Decomp
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Keywords
- Lumbar Canal Stenosis, Degenerative Spine Disease, Neurogenic Claudication, Sciatica, Low Back Pain, Segmental Decompression, Wide Decompression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental Decompression Alone | Active comparator | Procedure: Segmental DecompressionParticipants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis. |
| Wide Decompression with Fixation | Active comparator | Procedure: Wide Decompression with FixationParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age less than 40 years
- Recurrent cases and screw revision cases
- Degenerative scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Segmental DecompressionA 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. | Procedure or surgery | Segmental Decompression Alone |
| Wide Decompression with FixationA 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. | Procedure or surgery | Wide Decompression with Fixation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Segmental Decompression and Wide Decompression with Fixation in people with Degenerative Lumbar Spinal Stenosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery as Assessed by the Oswestry Disability Index (ODI) (time frame: Baseline, 3 months, 6 months, and 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.