Failed Back Surgery SyndromeNCT07050290
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
A study testing Restoring segmental lordosis at the lumbar spine in people with Failed Back Surgery Syndrome and Degeneration Lumbar Spine, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Degeneration Lumbar Spine, Degenerative Spondylolisthesis
- What is being tested?
- Restoring segmental lordosis at the lumbar spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
About this study
Official title: Restoring Segmental Lordosis Via One Previous Posterior Approach After Failed Fusion at the Same Level for Degenerative Lumbar Disease
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.
- Conditions
- Failed Back Surgery Syndrome, Degeneration Lumbar Spine, Degenerative Spondylolisthesis, Sagittal Imbalance
- Being tested
- Restoring segmental lordosis at the lumbar spine
- Keywords
- Lumbar fusion, segmental lordosis, revision spinal surgery, posterior approach
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoring segmental lordosis at the lumbar spineProcedure or surgery
All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level. Receives: Procedure: Restoring segmental lordosis at the lumbar spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lumbar balance parameters
To observe the change from baseline in segmental lordosis at operated level by CT, in degrees
Measured: 2 weeks postoperatively (or at day of hospital discharge)
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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.'')
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the interbody fusion grade by CT , grades by Tan
Measured: 12 months postoperatively
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Measured: during study, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start25 Jun 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050290
- Sponsor's protocol ID
- NS12-04
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Segmental Lordosis Via One Previous Posterior Approach After Failed Fusion at the Same Level for Degenerative Lumbar Disease
- ClinicalTrials.gov ID
- NCT07050290
- Acronym / sponsor ID
- NS12-04
- Conditions
- Failed Back Surgery Syndrome, Degeneration Lumbar Spine, Degenerative Spondylolisthesis, Sagittal Imbalance
- Keywords
- Lumbar fusion, segmental lordosis, revision spinal surgery, posterior approach
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and OrthopedicsUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Procedure: Restoring segmental lordosis at the lumbar spineAll patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoring segmental lordosis at the lumbar spineAll patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level. | Procedure or surgery | Cohort |
Primary outcome
Change from baseline in lumbar balance parameters
Time frame: 2 weeks postoperatively (or at day of hospital discharge)
To observe the change from baseline in segmental lordosis at operated level by CT, in degrees
9 secondary outcomes
Change from baseline in Numeric Pain Rating Scale
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index
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
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 12 months postoperatively
Adverse Events
Time frame: during study, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoring segmental lordosis at the lumbar spine in people with Failed Back Surgery Syndrome and Degeneration Lumbar Spine, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lumbar balance parameters (time frame: 2 weeks postoperatively (or at day of hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.