Status:
RECRUITING
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
Lead Sponsor:
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Collaborating Sponsors:
Burdenko Neurosurgery Institute
Pirogov National Medical Surgical Center
Conditions:
LUMBAR STENOSIS
Sagittal Imbalance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 1\. Age 45 and over;
- 2\. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;
- 3\. Planned isolated decompression of the spinal canal without implantation of any devices;
- 4\. Symptoms persisting for at least 3 months prior to surgery;
- 5\. Given written Informed Consent;
- 6\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
- Non-
- 1\. Prior any lumbar surgery;
- 2\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
- 3\. Degenerative scoliosis \> 20 degrees;
- 4\. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- 5\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
Exclusion
- 1\. Performed intraoperative discotomy;
- 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 6 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT07139938
Start Date
October 6 2025
End Date
October 6 2027
Last Update
December 11 2025
Active Locations (3)
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1
Pirogov National Medical Surgical Center
Moscow, Russia, 105203
2
Burdenko Neurosurgery Institute
Moscow, Russia, 125047
3
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, Russia, 127299