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

NAActive, not recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

December 30, 2024

Study Completion Date

December 30, 2026

Conditions
Lumbar Spinal StenosisSpinal StenosisSpinal 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.

Trial Locations (3)

105203

"Federal State Budgetary Institution Federal Center for Brain and Neurotechnologies FMBA", Moscow

Pirogov National Medical and Surgical Center, Moscow

107045

Sklifosovsky Research Institute for Emergency Medicine, Moscow

All Listed Sponsors
collaborator

Pirogov National Medical Surgical Center

OTHER_GOV

collaborator

"Federal State Budgetary Institution Federal Center for Brain and Neurotechnologies FMBA"

UNKNOWN

collaborator

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

OTHER

lead

Sklifosovsky Institute of Emergency Care

OTHER_GOV

NCT05273879 - Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis | Biotech Hunter | Biotech Hunter