Spontaneous correction of forward spinal balance after lumbar decompression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ortho-ped@mail.ru
• Phone: +7 495 744 40 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.