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

NCT05273879 | Recruiting DMC

• 1 other identifier: 03\2022
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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

Spinal Stenosis; Spinal Fusion; Lumbar Spinal Stenosis

Keywords

lumbar spine; lumbar fusion; laminotomy; decompression without fusion; lumbar stenosis

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).

  24 months

Secondary Outcomes (12)

• SF-36 v.1 scale (standard form)

  24 months

• EQ-5D-5L

  24 months

• Won-Korff Chronic Pain Syndrome Assessment Scale

  24 months

• Pain Catastrophizing Scale

  24 months

• Chronic Pain Coping Inventory

  24 months

Study Arms (2)

decompression group

OTHER

minimally invasive decompression without fusion

Procedure: decompression

fusion group

OTHER

minimally invasive decompression with trans-foraminal interbody fusion

Procedure: fusion

Interventions

decompression PROCEDURE

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.

decompression group

fusion PROCEDURE

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.

fusion group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of patients from 45 to 75 years;
• stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;
• clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);
• lack of effect from conservative therapy within 3 months;
• Informed consent to take part in the study.

You may not qualify if:

• spondylolisthesis more than 3 mm;
• spinal instability according to functional radiography;
• sagittal imbalance (type 4 according to C. Barrey);
• bone density of the vertebrae at the level of the operation is less than 100 HU;
• clinically significant spinal stenosis at 2 or more levels;
• previously performed surgeries on the spine;
• risk of anesthesia 4 or 5 according to ASA;
• inability to take part in control examinations within 2 years after the operation;
• participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead
• Pirogov National Medical Surgical Center: collaborator
• Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine: collaborator

Study Sites (2)

Pirogov National Medical and Surgical Center

Moscow, Moscow, 105203, Russia

RECRUITING

Sklifosovsky Research Institute for Emergency Medicine

Moscow, Moscow, 107045, Russia

RECRUITING

Related Publications (1)

• Grin A, Lvov I, Talypov A, Smirnov V, Kordonskiy A, Lebedev V, Zuev A, Senko I, Pogonchenkova I, Krylov V. Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial. Trials. 2023 Jul 10;24(1):451. doi: 10.1186/s13063-023-07486-8.

  PMID: 37430281 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Constriction, Pathologic

Interventions

Decompression; Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Andrey Grin, MD, PhD

  Sklifosovsky Research Institute for Emergency Medicine

  STUDY CHAIR

Central Study Contacts

Ivan Lvov, MD, PhD

CONTACT

+79265760074; dr.speleolog@gmail.com

Anton Kordonskiy, MD, PhD

CONTACT

+79265724547; akord.neuro@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior fellow

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 10, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study protocol will be available after march 2022. An interim analysis will be conducted when follow-up data is available at 12 months for at least 20 patients in each cohort. Final analysis will be presented after december 2026
• Access Criteria: the approval of institutional review board

Locations

RU (2)