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

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.

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Herniation
• Intervention / Treatment: Diagnostic test: Preoperative risk estimation of disc herniation recurrence

• Study Type: Observational
• Enrollment (Actual): 386

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 127299
    • Priorov National Medical Research Center of Traumatology and Orthopedics
  • Novosibirsk, Russia, 630091
    • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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	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	6, 12, 18, 24, 30, 36 months follow up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): February 25, 2026

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: February 1, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement
• Other Study ID Numbers: NS02-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No