Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07139938

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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