Degenerative SpondylolisthesisNCT07410871
Degenerative Spondylolisthesis Accompanying LSS: Do We Need Fusion?
An observational study of Degenerative Spondylolisthesis and Lumbar Spinal Stenosis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to compare clinical results of decompression alone using minimal invasive unilateral laminotomy for bilateral decompression versus classical decompression and instrumentation and fusion. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Spondylolisthesis, Lumbar Spinal Stenosis, Fusion
- What is being tested?
- Unilateral laminotomy decompression and Decompression and fusion
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 29 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective study was carried out on 52 patients.
Who may be able to join
- Age > 50 years.
- Both sexes.
- Patients with symptoms of lumbar spinal stenosis (LSS) (neurogenic claudication) confirmed by magnetic resonance imaging (MRI), and a degenerative spondylolisthesis measuring at least 3 mm at the stenotic level on a plain X-ray.
Who cannot join
- Patients with excessive foraminal stenosis (a deformed nerve root in the intervertebral foramen).
- Thoracolumbar scoliosis of greater than 20 degrees.
- Patients with significant instability in plan radiography dynamic study.
- Patients who had previous spine surgery at lumbar region.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare clinical results of decompression alone using minimal invasive unilateral laminotomy for bilateral decompression versus classical decompression and instrumentation and fusion.
Read the detailed description
The term "lumbar spinal stenosis" (LSS) describes the anatomical narrowing of the spinal canal, which occurs in older people because of spinal ageing.
Initial treatment is usually medical. Surgical management is recommended for patients with failed non-surgical trials. As claudication is always the main complain, lumbar canal decompression is the traditional surgical treatment.
Although adding instrumentation and fusion is not uncommon and widely used. In the literature, the benefit of fusion, is treating instability that causes degenerative spondylolisthesis, improve back pain if present, and avoid slippage progression, which possibly will occur with generous decompression and disruption of the posterior column.
- Being tested
- Unilateral laminotomy decompression, Decompression and fusion
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral laminotomy decompressionProcedure or surgery
Patients underwent unilateral laminotomy decompression.
Decompression and fusionProcedure or surgery
Patients underwent a posterior decompression, (either with or without preservation of midline bands) was followed by instrumentation using pedicle screws with rods and intervertebral fusion device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Unilateral laminotomy decompression) | Patients underwent unilateral laminotomy decompression. Receives: Procedure: Unilateral laminotomy decompression | |
| Group 2 (Decompression and fusion) | Patients underwent a posterior decompression, (either with or without preservation of midline bands) was followed by instrumentation using pedicle screws with rods and intervertebral fusion device. Receives: Procedure: Decompression and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of low back pain
Low back pain was assessed using the Oswestry Disability Index (ODI), 10-question self-report questionnaire to measure functional disability and quality of life. It yields a percentage score from 0% (no disability) to 100% (severe disability).
Measured: 14 months after the procedure
Secondary outcomes (2)
Degree of pain
Each patient was instructed about leg pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 14 months after the procedure
Incidence of complications
Incidence of complications were recorded.
Measured: 14 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2025
- Primary completion29 Jun 2025
- Study completion29 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed Basha, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410871
- Sponsor's protocol ID
- KFSIRB200-889
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degenerative Spondylolisthesis Accompanying LSS: Do We Need Fusion?
- ClinicalTrials.gov ID
- NCT07410871
- Acronym / sponsor ID
- KFSIRB200-889
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 29 Jun 2025 (actual)
- First posted
- 13 Feb 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.
This study aimed to compare clinical results of decompression alone using minimal invasive unilateral laminotomy for bilateral decompression versus classical decompression and instrumentation and fusion.
Detailed description
The term "lumbar spinal stenosis" (LSS) describes the anatomical narrowing of the spinal canal, which occurs in older people because of spinal ageing.
Initial treatment is usually medical. Surgical management is recommended for patients with failed non-surgical trials. As claudication is always the main complain, lumbar canal decompression is the traditional surgical treatment.
Although adding instrumentation and fusion is not uncommon and widely used. In the literature, the benefit of fusion, is treating instability that causes degenerative spondylolisthesis, improve back pain if present, and avoid slippage progression, which possibly will occur with generous decompression and disruption of the posterior column.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Unilateral laminotomy decompression) | – | Procedure: Unilateral laminotomy decompressionPatients underwent unilateral laminotomy decompression. |
| Group 2 (Decompression and fusion) | – | Procedure: Decompression and fusionPatients underwent a posterior decompression, (either with or without preservation of midline bands) was followed by instrumentation using pedicle screws with rods and intervertebral fusion device. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective study was carried out on 52 patients.
Key inclusion criteria (3 listed)
- Age > 50 years.
- Both sexes.
- Patients with symptoms of lumbar spinal stenosis (LSS) (neurogenic claudication) confirmed by magnetic resonance imaging (MRI), and a degenerative spondylolisthesis measuring at least 3 mm at the stenotic level on a plain X-ray.
Key exclusion criteria (4 listed)
- Patients with excessive foraminal stenosis (a deformed nerve root in the intervertebral foramen).
- Thoracolumbar scoliosis of greater than 20 degrees.
- Patients with significant instability in plan radiography dynamic study.
- Patients who had previous spine surgery at lumbar region.
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 |
|---|---|---|
| Unilateral laminotomy decompressionPatients underwent unilateral laminotomy decompression. | Procedure or surgery | Group 1 (Unilateral laminotomy decompression) |
| Decompression and fusionPatients underwent a posterior decompression, (either with or without preservation of midline bands) was followed by instrumentation using pedicle screws with rods and intervertebral fusion device. | Procedure or surgery | Group 2 (Decompression and fusion) |
Primary outcome
Assessment of low back pain
Time frame: 14 months after the procedure
Low back pain was assessed using the Oswestry Disability Index (ODI), 10-question self-report questionnaire to measure functional disability and quality of life. It yields a percentage score from 0% (no disability) to 100% (severe disability).
2 secondary outcomes
Degree of pain
Time frame: 14 months after the procedure
Incidence of complications
Time frame: 14 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Degenerative Spondylolisthesis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Spondylolisthesis and Lumbar Spinal Stenosis, run by Kafrelsheikh University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2026. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of low back pain (time frame: 14 months after the procedure). 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 13 Feb 2026.