Degenerative Spondylolisthesis Accompanying LSS: Do We Need Fusion?

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis; Fusion
• Intervention / Treatment: Procedure: Unilateral laminotomy decompression; Procedure: Decompression 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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A retrospective study was carried out on 52 patients.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Unilateral laminotomy decompression); Patients underwent unilateral laminotomy decompression.	Procedure: Unilateral laminotomy decompression; Patients underwent 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	14 months after the procedure
Incidence of complications	Incidence of complications were recorded.	14 months after the procedure

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 29, 2025
• Study Completion (Actual): June 29, 2025

Study Registration Dates

• First Submitted: February 7, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis; Therapeutics; Mechanical Phenomena; Physical Phenomena; Genetic Phenomena; Recombination, Genetic; Pressure; Gene Fusion; Decompression
• Other Study ID Numbers: KFSIRB200-889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No