NCT07050290 Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
| NCT ID | NCT07050290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | N.N. Priorov National Medical Research Center of Traumatology and Orthopedics |
| Condition | Failed Back Surgery Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2026-07-25 |
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 20 participants in total. It began in 2025-06-25 with a primary completion date of 2026-07-25.
⚠ 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
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07050290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Failed Back Surgery Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07050290 currently recruiting?
Yes, NCT07050290 is actively recruiting participants. Contact the research team at ortho-ped@mail.ru for enrollment information.
Where is the NCT07050290 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07050290 clinical trial?
NCT07050290 is sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics. The trial plans to enroll 20 participants.