Intervertebral Disc HerniationNCT04254250
Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
An observational study of Intervertebral Disc Herniation, run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 2 sites in Russia.
Trial summary
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia. The current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intervertebral Disc Herniation
- What is being tested?
- Preoperative risk estimation of disc herniation recurrence
- How many people
- 386 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Feb 2020to 25 Feb 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with radicular leg pain with or without back pain secondary to single level disc herniation with neural compression confirmed on MRI and symptoms persisting for at least four weeks prior to surgery
Who may be able to join
- Age 18 to 60 years;
- Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
- Radicular leg pain with or without back pain;
- Symptoms persisting for at least four weeks prior to surgery;
- Given written Informed Consent;
- Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
- Visual Analogue Scale score at least 40/100 at baseline.
Who cannot join
- More than one symptomatic level requiring multilevel surgical decompression
- Stenosis any etiology at the same level;
- Spondylolisthesis any etiology at the same level;
- Prior lumbar spinal surgery at any level;
- Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
- Concurrent participation in another clinical study that may confound study results.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, 630091
About this study
Official title: Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .
It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.
- Conditions
- Intervertebral Disc Herniation
- Being tested
- Preoperative risk estimation of disc herniation recurrence
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative risk estimation of disc herniation recurrenceDiagnostic test
Risk estimation of disc herniation recurrence will be evaluated preoperatively, depend on the risk significance each patient will be assigned to one of two groups - with high risk and low risk. Then each patient will undergo conventional one-level microdiscectomy.
| Study group | Role | What they receive |
|---|---|---|
| High risk recurrence group | Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. Receives: Diagnostic Test: Preoperative risk estimation of disc herniation recurrence | |
| Low risk recurrence group | Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. Receives: Diagnostic Test: Preoperative risk estimation of disc herniation recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reherniation rate
Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side
Measured: at 3 years follow-up term postoperatively
Secondary outcomes (4)
Improvement of Oswestry Disability Index (ODI)
To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all).
Measured: 6, 12, 18, 24, 30, 36 months follow up
Improvement of Visual analog scale (VAS) leg pain intensity
To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.
Measured: 6, 12, 18, 24, 30, 36 months follow up
Change from baseline in EQ-5D (EuroQl - 5 dimensional)
To observe change in EQ-5Dl as compared to baseline
Measured: 6, 12, 18, 24, 30, 36 months follow up
HTI Item (from SF-36)
To observe the HTI Item (from SF-36) as compared to baseline
Measured: 6, 12, 18, 24, 30, 36 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Feb 2020
- Primary completion10 Aug 2023
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc HerniationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254250
- Sponsor's protocol ID
- NS02-03
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT04254250
- Acronym / sponsor ID
- NS02-03
- Conditions
- Intervertebral Disc Herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. TsivyanOther government
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 5 Feb 2020 (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.
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .
It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk recurrence group | – | Diagnostic Test: Preoperative risk estimation of disc herniation recurrenceDue to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. |
| Low risk recurrence group | – | Diagnostic Test: Preoperative risk estimation of disc herniation recurrenceDue to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with radicular leg pain with or without back pain secondary to single level disc herniation with neural compression confirmed on MRI and symptoms persisting for at least four weeks prior to surgery
Key inclusion criteria (7 listed)
- Age 18 to 60 years;
- Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
- Radicular leg pain with or without back pain;
- Symptoms persisting for at least four weeks prior to surgery;
- Given written Informed Consent;
Key exclusion criteria (6 listed)
- More than one symptomatic level requiring multilevel surgical decompression
- Stenosis any etiology at the same level;
- Spondylolisthesis any etiology at the same level;
- Prior lumbar spinal surgery at any level;
- Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
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 |
|---|---|---|
| Preoperative risk estimation of disc herniation recurrenceRisk estimation of disc herniation recurrence will be evaluated preoperatively, depend on the risk significance each patient will be assigned to one of two groups - with high risk and low risk. Then each patient will undergo conventional one-level microdiscectomy. | Diagnostic test | High risk recurrence group, Low risk recurrence group |
Primary outcome
Reherniation rate
Time frame: at 3 years follow-up term postoperatively
Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side
4 secondary outcomes
Improvement of Oswestry Disability Index (ODI)
Time frame: 6, 12, 18, 24, 30, 36 months follow up
Improvement of Visual analog scale (VAS) leg pain intensity
Time frame: 6, 12, 18, 24, 30, 36 months follow up
Change from baseline in EQ-5D (EuroQl - 5 dimensional)
Time frame: 6, 12, 18, 24, 30, 36 months follow up
HTI Item (from SF-36)
Time frame: 6, 12, 18, 24, 30, 36 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Herniation, run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 2 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reherniation rate (time frame: at 3 years follow-up term postoperatively). 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 27 Feb 2026.