Fusion versus decompression alone for single-level lumbar stenosis

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 randomized trial will enroll 86 adults with single‑level lumbar stenosis and assign them 1:1 to decompression that preserves posterior elements or to decompression plus transforaminal interbody fusion. Surgeons will use a standardized operative protocol and postoperative rehabilitation to maximize homogeneity between groups. The primary outcome is change in the Oswestry Disability Index at 24 months, and secondary outcomes include SF‑36, EQ‑5D‑5L, psychological scales, sagittal balance, fusion status, and total cost over two years. Patients will be followed at 3, 6, 12, and 24 months to capture clinical, radiographic, and economic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age of patients from 45 to 75 years;
* stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;
* clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);
* lack of effect from conservative therapy within 3 months;
* Informed consent to take part in the study.

Exclusion Criteria:

* spondylolisthesis more than 3 mm;
* spinal instability according to functional radiography;
* sagittal imbalance (type 4 according to C. Barrey);
* bone density of the vertebrae at the level of the operation is less than 100 HU;
* clinically significant spinal stenosis at 2 or more levels;
* previously performed surgeries on the spine;
* risk of anesthesia 4 or 5 according to ASA;
* inability to take part in control examinations within 2 years after the operation;
* participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.

Where it's running

• Pirogov National Medical and Surgical Center
  Moscow, Moscow, Russia Recruiting
• Sklifosovsky Research Institute for Emergency Medicine
  Moscow, Moscow, Russia Recruiting

Study contacts

• Study coordinator: Ivan Lvov, MD, PhD
• Email: dr.speleolog@gmail.com
• Phone: +79265760074

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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.