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Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

NCT05273879 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-12-18

No results posted yet for this study

Summary

Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups.

This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.

Conditions

  • Lumbar Spinal Stenosis
  • Spinal Stenosis
  • Spinal Fusion

Interventions

PROCEDURE

decompression

laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.

PROCEDURE

fusion

First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.

Sponsors & Collaborators

  • Pirogov National Medical Surgical Center

    collaborator OTHER_GOV

  • Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

    collaborator OTHER

  • Sklifosovsky Institute of Emergency Care

    lead OTHER_GOV

Principal Investigators

  • Andrey Grin, MD, PhD · Sklifosovsky Research Institute for Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273879 on ClinicalTrials.gov