An interventional study of Restoring segmental lordosis at the lumbar spine in Failed Back Surgery Syndrome, Degeneration Lumbar Spine and Degenerative Spondylolisthesis, sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics. Active, not recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Not applicable, Interventional, and Treatment
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.
98 studies on the registry are indexed under Failed Back Surgery Syndrome; 16 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 71 interventional studies indexed under Failed Back Surgery Syndrome.
Browse Failed Back Surgery Syndrome studies →N.N. Priorov National Medical Research Center of Traumatology and Orthopedics is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.
Procedure: Restoring segmental lordosis at the lumbar spine
All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.
Change from baseline in lumbar balance parameters
To observe the change from baseline in segmental lordosis at operated level by CT, in degrees
Time frame: 2 weeks postoperatively (or at day of hospital discharge)
Change from baseline in Numeric Pain Rating Scale
To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36
To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'')
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in degrees
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in full balance integrated index by full body X-Ray, in degrees
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the interbody fusion grade by CT , grades by Tan
Time frame: 12 months postoperatively
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Time frame: during study, an average of 12 months
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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N.N. Priorov National Medical Research Center of Traumatology and Orthopedics