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Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Burdenko Neurosurgery Institute
RECRUITING
Moscow
Pirogov National Medical Surgical Center
RECRUITING
Moscow
Priorov National Medical Research Center of Traumatology and Orthopedics
RECRUITING
Moscow
Contact Information
Primary
Aleksandr Krutko, MD, PhD
ortho-ped@mail.ru
+7 495 744 40 11
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2027-10-06
Participants
Target number of participants: 165
Treatments
Other: Cohort
Isolated lumbar decompression
Related Therapeutic Areas
Sponsors
Collaborators: Burdenko Neurosurgery Institute, Pirogov National Medical Surgical Center
Leads: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

This content was sourced from clinicaltrials.gov