NCT07542054

Brief Summary

The purpose of this study is to compare two different surgical techniques for treating degenerative lumbar canal stenosis, a condition where the lower spinal canal narrows and puts pressure on the spinal nerves. For patients who continue to experience significant back and leg pain after at least three months of non-surgical treatments, surgery is often recommended to relieve the pressure. Currently, there is an ongoing debate among spine surgeons regarding the most effective surgical approach. This study will evaluate and compare the outcomes of two established methods:

  1. 1.Segmental Decompression Alone: A procedure focused purely on removing the bone and tissue that is pressing on the spinal nerves.
  2. 2.Wide Decompression with Fixation: A more extensive removal of compressive structures, combined with adding spinal hardware (pedicle screws and rods) to stabilize the spine.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Lumbar Canal StenosisDegenerative Spine DiseaseNeurogenic ClaudicationSciaticaLow Back PainSegmental DecompressionWide Decompression

Outcome Measures

Primary Outcomes (1)

  • Functional Recovery as Assessed by the Oswestry Disability Index (ODI)

    Functional disability will be quantified using the Oswestry Disability Index (ODI) questionnaire. The ODI is a validated index scored from 0 to 100, where 0 indicates no disability and 100 indicates maximum possible disability. A decrease in the score from baseline indicates functional improvement and a better surgical outcome.

    Baseline, 3 months, 6 months, and 12 months postoperative

Study Arms (2)

Segmental Decompression Alone

ACTIVE COMPARATOR

Participants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.

Procedure: Segmental Decompression

Wide Decompression with Fixation

ACTIVE COMPARATOR

Participants in this arm will undergo wide surgical decompression combined with spinal fixation utilizing pedicle screws and rods for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.

Procedure: Wide Decompression with Fixation

Interventions

A surgical technique involving the targeted removal of compressive structures in the lumbar spine to relieve neurogenic claudication and leg pain, performed without the addition of spinal instrumentation or fusion.

Segmental Decompression Alone

A surgical technique that combines extensive decompression of the lumbar canal with spinal instrumentation. This involves the application of pedicle screws and rods across varying segment lengths to provide stabilization to the affected spine.

Wide Decompression with Fixation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 40 years
  • Both males and females
  • Multilevel lumbar canal stenosis with failed routine conservative treatment at least 3 months
  • X-ray dynamic views of the lumbar spine showing no evidence of instability

You may not qualify if:

  • Age less than 40 years
  • Recurrent cases and screw revision cases
  • Degenerative scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SciaticaLow Back Pain

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Neurosurgery Department, Misr University for Science and Technology

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04