Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level (NCT07050290) | Clinical Trial Compass
RecruitingNot Applicable
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Russia20 participantsStarted 2025-06-25
Plain-language summary
The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life in the follow-up. Revision surgery to restore segmental lordosis at the level of previous spinal fusion is extremely difficult to do and its performance is usually inferior to that of primary surgery. Need to provide a surgical technique to restore segmental lordosis via a posterior approach, which is especially important after failed previous fusion at the same lumbar level.
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\. Over 18 years' old;
* 2\. Lumbar back pain with / without radicular leg pain (with / without neurological deficit) with / without neurogenic claudication, symptoms persisting for at least 3 months prior to surgery;
* 3\. 1) Failed back lumbar fusion surgery at the same level or on an adjacent segment or 2) Symptomatic discopathy with loss of segmental lordosis at one of the levels L3-L4, L4-L5 or L5-S1, confirmed by MRI и Rg, with/without degenerative stenosis/spondylolisthesis
* 4\. Need for a planned surgical procedure with a major extent of segmental lordosis restoration (more than 10°);
* 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
Exclusion Criteria:
* 1\. Interbody implants previously placed via non-posterior approach at the level of surgery (which cannot be removed through the posterior approach);
* 2\. Complete interbody fusion after previous surgery at the level of surgery;
* 3\. HU values of lumbar body vertebrae less than 120 HU;
* 4\. Any contraindication or inability to undergo baseline and/or follow up MRI, CT or X-ray as required per protocol;
* 5\. Back or non-radicular pain of unknown etiology;
* 6\. History or presence of any other major neurological disease or condition that may interfere with the study assessments;
* 7\. Previous enrollment in this study, current enrollment or plans to be enrolled in another stud…
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: 2 weeks postoperatively (or at day of hospital discharge)
Trial details
NCT IDNCT07050290
SponsorN.N. Priorov National Medical Research Center of Traumatology and Orthopedics