Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression (NCT07139938) | Clinical Trial Compass
RecruitingNot Applicable
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
Russia165 participantsStarted 2025-10-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in lumbar balance parameters
Timeframe: 3 months postoperatively
Trial details
NCT IDNCT07139938
SponsorN.N. Priorov National Medical Research Center of Traumatology and Orthopedics