Degenerative Spondylolisthesis Accompanying LSS: Do We Need Fusion?

NCT07410871 | Completed

• 1 other identifier: KFSIRB200-889
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Spondylolisthesis; Lumbar Spinal Stenosis; Fusion

Outcome Measures

Primary Outcomes (1)

• 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).

  14 months after the procedure

Secondary Outcomes (2)

• Degree of pain

  14 months after the procedure

• Incidence of complications

  14 months after the procedure

Study Arms (2)

Group 1 (Unilateral laminotomy decompression)

Patients underwent unilateral laminotomy decompression.

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.

Procedure: Decompression and fusion

Interventions

Unilateral laminotomy decompression PROCEDURE

Patients underwent unilateral laminotomy decompression.

Group 1 (Unilateral laminotomy decompression)

Decompression and fusion PROCEDURE

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.

Group 2 (Decompression and fusion)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A retrospective study was carried out on 52 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Decompression; Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: January 1, 2025
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)