Actively Recruiting
Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion for Lumbar Spinal Stenosis
Led by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Updated on 2025-12-11
165
Participants Needed
3
Research Sites
52 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
This research aims to understand whether isolated decompression surgery can lead to spontaneous correction of sagittal spinal imbalance in patients with degenerative lumbar stenosis. Sagittal imbalance may result from orthopedic issues, nerve compression in the spinal canal, and pain-related functional imbalance. While surgical correction with spine fixation is often needed, some patients show improvement after decompression alone, making this study important to clarify treatment effects. Participants will undergo isolated lumbar decompression surgery, which involves microsurgical relief of pressure on the neural structures of the lumbar spine without fusion or corrective fixation. The decompression can be unilateral, bilateral, or bilateral from a unilateral approach, including endoscopic methods. This procedure targets degenerative changes such as thickened ligaments, joint hypertrophy, bone spurs, and cysts contributing to stenosis. During the study, researchers will measure changes in lumbar balance parameters at 3 and 12 months after surgery, along with assessments of disability, pain, neuropathic symptoms, posture alignment, and the size of the dural sac. Safety will be monitored over an average of 12 months. Participants must follow the clinical protocol and attend scheduled follow-up visits to assess surgical outcomes and spinal alignment changes.
CONDITIONS
Brief 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 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 requirements
You will not qualify if you...
- Prior any lumbar surgery
- Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.)
- Degenerative scoliosis greater than 20 degrees
- Any contraindication or inability to undergo baseline and/or follow-up MRI or X-ray as required
- Any other condition that may interfere with safety or study conduct as judged by the investigator
- Performed intraoperative discotomy
- Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay until discharge
Participants undergo isolated lumbar decompression surgery to relieve pressure on neural structures in the lumbar spine.
1 surgery visit and hospital stay until discharge
Duration - Up to 12 months postoperatively
Participants are monitored for recovery and changes in lumbar balance, pain, and disability after surgery.
Visits at 2 weeks (or day of discharge), 3 months, and 12 months postoperatively
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
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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