Actively Recruiting
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
Led by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Updated on 2025-12-11
165
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Lead Sponsor
B
Burdenko Neurosurgery Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.
CONDITIONS
Official Title
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 and over
- Radicular leg pain and/or neurogenic claudication with or without back pain caused by single- or multi-level degenerative lumbar stenosis confirmed by MRI
- Planned isolated decompression of the spinal canal without implantation of any devices
- Symptoms persisting for at least 3 months prior to surgery
- Given written informed consent
- Able and agree to fully comply with the clinical protocol and follow-up schedule
You will not qualify if you...
- Prior any lumbar surgery
- Scoliosis of any non-degenerative cause
- Degenerative scoliosis greater than 20 degrees
- Contraindication or inability to undergo baseline or follow-up MRI or X-ray
- Any condition that may interfere with safety or study conduct as judged by investigator
- Performed intraoperative discotomy
- Performed intraoperative iatrogenic instability of the lumbar segment (e.g., facetectomy, foraminotomy)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Pirogov National Medical Surgical Center
Moscow, Russia, 105203
Actively Recruiting
2
Burdenko Neurosurgery Institute
Moscow, Russia, 125047
Actively Recruiting
3
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, Russia, 127299
Actively Recruiting
Research Team
A
Aleksandr Krutko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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