Spontaneous correction of forward spinal balance after lumbar decompression

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

This will see if isolated lumbar decompression can correct forward (sagittal) spinal imbalance in adults 45 and older with degenerative lumbar stenosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics (other)
• Locations: 3 sites (Moscow and 2 other locations)
• Trial ID: NCT07139938 on ClinicalTrials.gov

What this trial studies

This interventional study follows patients with MRI-confirmed degenerative lumbar stenosis who are scheduled for isolated lumbar decompression without any implants. Eligible patients are aged 45 or older, have at least three months of radicular leg pain or neurogenic claudication, and have not had prior lumbar surgery. Preoperative and follow-up imaging (X-ray and MRI) and clinical exams are used to determine whether sagittal alignment improves spontaneously after decompression. Patients with significant scoliosis or other contraindications to imaging are excluded, and follow-up visits occur at the participating Moscow centers.

Who should consider this trial

Good fit: Adults aged 45 and over with MRI-confirmed degenerative lumbar stenosis (with or without low-grade spondylolisthesis), at least three months of relevant symptoms, and planned isolated decompression without instrumentation are ideal candidates.

Not a fit: Patients with prior lumbar surgery, non-degenerative scoliosis, degenerative scoliosis over 20 degrees, or those who require fusion or instrumentation are unlikely to benefit from isolated decompression for sagittal correction.

Why it matters

Potential benefit: If successful, some patients might avoid more extensive corrective fusion surgery because decompression alone could restore sagittal alignment.

How similar studies have performed: Case series and reports have described spontaneous sagittal improvement after decompression, but larger systematic evidence is limited.

Eligibility criteria

Inclusion Criteria:

* 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-Inclusion Criteria:

* 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 Criteria:

* 1\. Performed intraoperative discotomy;
* 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)

Where this trial is running

Moscow and 2 other locations

• Pirogov National Medical Surgical Center — Moscow, Russia (RECRUITING)
• Burdenko Neurosurgery Institute — Moscow, Russia (RECRUITING)
• Priorov National Medical Research Center of Traumatology and Orthopedics — Moscow, Russia (RECRUITING)

Study contacts

• Study coordinator: Aleksandr Krutko, MD, PhD

Conditions: LUMBAR STENOSIS, Sagittal Imbalance, Degeneration Lumbar Spine, Lumbar Decompression, lumbar stenosis, sagittal imbalance, lumbar decompression