Lumbar Spinal StenosisEarly Phase 1NCT07281625
Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis
A Early Phase 1 study testing Decompressive Laminectomy and Decompressive Laminectomy With Transpedicular Screw Fixation in people with Lumbar Spinal Stenosis, run by Punjab Health Care Commission at 1 site in Pakistan.
Trial summary
Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Decompressive Laminectomy and Decompressive Laminectomy With Transpedicular Screw Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 31 Dec 2025
- Phase
- Early Phase 1
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-60 years
- Diagnosis of lumbar spinal stenosis based on MRI criteria (anteroposterior canal diameter <10-15 mm or cross-sectional area <75-145 mm²)
- Multilevel disc herniation
- Degenerative disc disease with Pfirrmann grade 3-5 on T2-weighted MRI
- Failure of at least six weeks of conservative treatment
Who cannot join
- Previous history of lumbar spine surgery
- Spinal malignancy
- Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis
- Lumbar spondylolisthesis grade 3-5
- Significant comorbidities including diabetes mellitus or ischemic heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Services Institute of Medical Sciences
Lahore, Punjab Province, 60000
Burhan Amjad, MBBS, +92 300 5457200, info.health@punjab.gov.pk
Madiha Suleman, MBBS, 03238092608, info.health@punjab.gov.pk
About this study
Official title: A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis
Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment.
This study will compare two types of surgery used to treat lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy with transpedicular screw fixation. Patients will be randomly assigned to one of the two surgical options.
The purpose of this study is to determine which approach provides better pain relief, improved function, fewer complications, and better spinal stability after surgery.
Read the detailed description
Lumbar spinal stenosis (LSS) is a common degenerative spinal disorder causing neurogenic claudication, back pain, radiculopathy, and functional limitation. Multilevel stenosis is frequently associated with degenerative disc disease and facet joint hypertrophy. Decompressive laminectomy is a widely performed procedure; however, concerns exist regarding postoperative instability, which may affect long-term outcomes. Instrumented fixation using transpedicular screws may provide stability but also increases operative time, surgical risk, and healthcare cost.
This randomized controlled trial will be conducted at the Department of Neurosurgery, Services Hospital Lahore, over a six-month period. A total of 60 participants aged 30-60 years with MRI-confirmed multilevel lumbar spinal stenosis who have failed six weeks of conservative treatment will be enrolled using consecutive sampling and randomized into two equal study groups. Group A will undergo decompressive laminectomy alone, while Group B will undergo decompressive laminectomy with transpedicular screw fixation.
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Outcome measures will include operative time, postoperative complications, length of hospital stay, pain assessed using the Visual Analog Scale (VAS) at baseline, day 7, and 3 months, and functional status assessed using the Oswestry Disability Index (ODI) at baseline and 3 months. Postoperative radiographs will be used to evaluate spinal stability and bony fusion at 3 months.
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Data will be analyzed using SPSS version 25. Continuous variables will be presented as mean ± standard deviation and analyzed using an independent sample t-test. Categorical variables will be compared using the chi-square test, with a significance threshold of p ≤ 0.05. The study aims to evaluate whether decompression alone or decompression with transpedicular fixation results in superior clinical and radiological outcomes.
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- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Decompressive Laminectomy, Decompressive Laminectomy With Transpedicular Screw Fixation
- Keywords
- laminectomy, spinal stenosis, lumbar fusion, VAS pain score
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive LaminectomyProcedure or surgery
Surgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied.
Decompressive Laminectomy With Transpedicular Screw FixationProcedure or surgery
Surgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion.
| Study group | Role | What they receive |
|---|---|---|
| Decompressive Laminectomy Only | Active comparator | Surgical decompressive laminectomy performed without instrumented fixation in patients with multilevel lumbar spinal stenosis. Receives: Procedure: Decompressive Laminectomy; Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation |
| Laminectomy With Transpedicular Screw Fixation | Experimental | Surgical decompressive laminectomy combined with transpedicular screw fixation to provide additional spinal stability in patients with multilevel lumbar spinal stenosis. Receives: Procedure: Decompressive Laminectomy; Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI)
Functional disability will be assessed using the Oswestry Disability Index (ODI), recorded preoperatively and at 3-month follow-up to measure improvement in functional outcome.
Measured: Baseline and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Punjab Health Care Commission
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Umar, Services Institute of Medical Sciences, Pakistan
- Investigators
- Hira Umar, MBBS, Principal investigator, SIMS SIUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281625
- Sponsor's protocol ID
- SHL-LSS-Trial
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plans for sharing individual participant data have not yet been finalized. Data sharing may be limited by institutional policy, ethical requirements, and patient confidentiality considerations. If a data-sharing framework is approved in the future, the plan will be updated in this record.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07281625
- Acronym / sponsor ID
- SHL-LSS-Trial
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- laminectomy, spinal stenosis, lumbar fusion, VAS pain score
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Punjab Health Care CommissionUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Dec 2025 (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.
Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment.
This study will compare two types of surgery used to treat lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy with transpedicular screw fixation. Patients will be randomly assigned to one of the two surgical options.
The purpose of this study is to determine which approach provides better pain relief, improved function, fewer complications, and better spinal stability after surgery.
Detailed description
Lumbar spinal stenosis (LSS) is a common degenerative spinal disorder causing neurogenic claudication, back pain, radiculopathy, and functional limitation. Multilevel stenosis is frequently associated with degenerative disc disease and facet joint hypertrophy. Decompressive laminectomy is a widely performed procedure; however, concerns exist regarding postoperative instability, which may affect long-term outcomes. Instrumented fixation using transpedicular screws may provide stability but also increases operative time, surgical risk, and healthcare cost.
This randomized controlled trial will be conducted at the Department of Neurosurgery, Services Hospital Lahore, over a six-month period. A total of 60 participants aged 30-60 years with MRI-confirmed multilevel lumbar spinal stenosis who have failed six weeks of conservative treatment will be enrolled using consecutive sampling and randomized into two equal study groups. Group A will undergo decompressive laminectomy alone, while Group B will undergo decompressive laminectomy with transpedicular screw fixation.
b2bf342f-1787-4c2e-828b-e000ffb…
Outcome measures will include operative time, postoperative complications, length of hospital stay, pain assessed using the Visual Analog Scale (VAS) at baseline, day 7, and 3 months, and functional status assessed using the Oswestry Disability Index (ODI) at baseline and 3 months. Postoperative radiographs will be used to evaluate spinal stability and bony fusion at 3 months.
b2bf342f-1787-4c2e-828b-e000ffb…
Data will be analyzed using SPSS version 25. Continuous variables will be presented as mean ± standard deviation and analyzed using an independent sample t-test. Categorical variables will be compared using the chi-square test, with a significance threshold of p ≤ 0.05. The study aims to evaluate whether decompression alone or decompression with transpedicular fixation results in superior clinical and radiological outcomes.
b2bf342f-1787-4c2e-828b-e000ffb…
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompressive Laminectomy Only | Active comparator | Procedure: Decompressive Laminectomy, Procedure: Decompressive Laminectomy With Transpedicular Screw FixationSurgical decompressive laminectomy performed without instrumented fixation in patients with multilevel lumbar spinal stenosis. |
| Laminectomy With Transpedicular Screw Fixation | Experimental | Procedure: Decompressive Laminectomy, Procedure: Decompressive Laminectomy With Transpedicular Screw FixationSurgical decompressive laminectomy combined with transpedicular screw fixation to provide additional spinal stability in patients with multilevel lumbar spinal stenosis. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 30-60 years
- Diagnosis of lumbar spinal stenosis based on MRI criteria (anteroposterior canal diameter <10-15 mm or cross-sectional area <75-145 mm²)
- Multilevel disc herniation
- Degenerative disc disease with Pfirrmann grade 3-5 on T2-weighted MRI
- Failure of at least six weeks of conservative treatment
Key exclusion criteria (5 listed)
- Previous history of lumbar spine surgery
- Spinal malignancy
- Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis
- Lumbar spondylolisthesis grade 3-5
- Significant comorbidities including diabetes mellitus or ischemic heart disease
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 |
|---|---|---|
| Decompressive LaminectomySurgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied. | Procedure or surgery | Decompressive Laminectomy Only, Laminectomy With Transpedicular Screw Fixation |
| Decompressive Laminectomy With Transpedicular Screw FixationSurgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion. | Procedure or surgery | Decompressive Laminectomy Only, Laminectomy With Transpedicular Screw Fixation |
Primary outcome
Change in Oswestry Disability Index (ODI)
Time frame: Baseline and 3 months after surgery
Functional disability will be assessed using the Oswestry Disability Index (ODI), recorded preoperatively and at 3-month follow-up to measure improvement in functional 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 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. Plans for sharing individual participant data have not yet been finalized. Data sharing may be limited by institutional policy, ethical requirements, and patient confidentiality considerations. If a data-sharing framework is approved in the future, the plan will be updated in this record.
Related trials for Lumbar Spinal Stenosis
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Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
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MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
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Thoracic-Lumbar Arthrodesis- Implanet Jazz
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Surgical Treatment of Adjacent Segment Stenosis
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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.
Hira Umar, MBBS principal investigator
SIMS SIUT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Decompressive Laminectomy and Decompressive Laminectomy With Transpedicular Screw Fixation in people with Lumbar Spinal Stenosis, run by Punjab Health Care Commission at 1 site in Pakistan.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Hira Umar, MBBS (+92 317 4226862, quickcareclinicdr03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: Baseline and 3 months after surgery). 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 15 Dec 2025.