Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level

Launched by N.N. PRIOROV NATIONAL MEDICAL RESEARCH CENTER OF TRAUMATOLOGY AND ORTHOPEDICS · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical technique to help people who have had back surgery that didn’t work as planned, specifically in the lower spine. The focus is on fixing problems with the natural curve of the lower back (called lumbar lordosis) after a previous spinal fusion surgery has failed. Restoring this curve is important because it can improve how the spine functions and help reduce pain or discomfort. The surgery is done from the back of the spine and aims to correct the curve at the exact spot where the earlier surgery didn’t succeed, which is usually a challenging area to treat.

People who might be eligible are adults over 18 who have ongoing lower back pain, possibly with leg pain or difficulty walking, lasting at least three months. They may have had a previous spinal fusion surgery that didn’t relieve their symptoms or have a damaged disc with loss of the spine’s natural curve in certain lower back areas, confirmed by imaging tests like MRI or X-rays. Participants in this study will undergo the new surgical procedure and will need to agree to follow all the study’s instructions and attend follow-up visits. It’s important to know that some people won’t qualify, such as those who have certain types of implants already in place or other health issues that could affect the study. Overall, this trial aims to find a better way to improve spine alignment and quality of life for patients with complicated back surgery histories.

Gender

ALL

Eligibility criteria

• 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 study (in parallel to this study).