Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorSklifosovsky Institute of Emergency Care
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- decompression
- fusion
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sklifosovsky Institute of Emergency Care
Lead sponsor
Pirogov National Medical Surgical Center
Collaborator
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Collaborator
Source ClinicalTrials.gov