NCT07139938 Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
| NCT ID | NCT07139938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | N.N. Priorov National Medical Research Center of Traumatology and Orthopedics |
| Condition | LUMBAR STENOSIS |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2026-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 165 participants in total. It began in 2025-10-06 with a primary completion date of 2026-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07139938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying LUMBAR STENOSIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07139938 currently recruiting?
Yes, NCT07139938 is actively recruiting participants. Contact the research team at ortho-ped@mail.ru for enrollment information.
Where is the NCT07139938 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia, Moscow, Russia.
Who is sponsoring the NCT07139938 clinical trial?
NCT07139938 is sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics. The trial plans to enroll 165 participants.