Skip to main content
OpenTrials
Completed

NCT Number: NCT07410871

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unilateral laminotomy decompression

Procedure

Patients underwent 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Degree of pain

    Time frame: 14 months after the procedure

    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").

  2. Incidence of complications

    Time frame: 14 months after the procedure

    Incidence of complications were recorded.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.