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NCT Number: NCT04254250

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.

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Key information

Conditions

Intervertebral Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Priorov National Medical Research Center of Traumatology and Orthopedics, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Preoperative risk estimation of disc herniation recurrence

Diagnostic 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Improvement of Oswestry Disability Index (ODI)

    Time frame: 6, 12, 18, 24, 30, 36 months follow up

    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).

  2. Improvement of Visual analog scale (VAS) leg pain intensity

    Time frame: 6, 12, 18, 24, 30, 36 months follow up

    To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.

  3. Change from baseline in EQ-5D (EuroQl - 5 dimensional)

    Time frame: 6, 12, 18, 24, 30, 36 months follow up

    To observe change in EQ-5Dl as compared to baseline

  4. HTI Item (from SF-36)

    Time frame: 6, 12, 18, 24, 30, 36 months follow up

    To observe the HTI Item (from SF-36) as compared to baseline

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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