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New study aims to predict repeat disc herniations before surgery

NCT ID NCT04254250

Knowledge-focused Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 386 people who had surgery for a slipped disc in the lower back. Before surgery, doctors used a mathematical model to estimate each patient's risk of the disc herniating again. After standard microdiscectomy, patients were checked every 6 months for 3 years to see if the disc came back. The goal was to see if the risk estimate could accurately predict reherniation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help surgeons identify patients at high risk of reherniation before surgery, potentially guiding treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It only estimates risk and does not test a new therapy, so direct patient benefit is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

386 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- 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; 1. Radicular leg pain with or without back pain; 2. Symptoms persisting for at least four weeks prior to surgery; 3. Given written Informed Consent; 4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements; 5. Visual Analogue Scale score at least 40/100 at baseline. Exclusion Criteria: 1. More than one symptomatic level requiring multilevel surgical decompression 2. Stenosis any etiology at the same level; 3. Spondylolisthesis any etiology at the same level; 4. Prior lumbar spinal surgery at any level; 5. 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 6. Concurrent participation in another clinical study that may confound study results.

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Conditions

The condition(s) this trial relates to.

Intervertebral Disc Displacement lumbar disk herniation, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intervertebral disc herniation

Contacts and locations

Locations

  • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

    Novosibirsk, 630091, Russia

  • Priorov National Medical Research Center of Traumatology and Orthopedics

    Moscow, 127299, Russia

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