Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation

NCT04254250 | Completed DMC

• 1 other identifier: NS02-03
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 2

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Reherniation rate

  Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side

  at 3 years follow-up term postoperatively

Secondary Outcomes (4)

• Improvement of Oswestry Disability Index (ODI)

  6, 12, 18, 24, 30, 36 months follow up

• Improvement of Visual analog scale (VAS) leg pain intensity

  6, 12, 18, 24, 30, 36 months follow up

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

  6, 12, 18, 24, 30, 36 months follow up

• HTI Item (from SF-36)

  6, 12, 18, 24, 30, 36 months follow up

Study Arms (2)

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.

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.

Diagnostic Test: Preoperative risk estimation of disc herniation recurrence

Interventions

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.

High risk recurrence group; Low risk recurrence group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Location

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

Novosibirsk, 630091, Russia

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 5, 2020
• Study Start: February 10, 2020
• Primary Completion: August 10, 2023
• Study Completion: February 25, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

RU (2)