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

Active, not recruiting

• Conditions: Intervertebral Disc Herniation
• Interventions: Diagnostic Test: Preoperative risk estimation of disc herniation recurrence

• Registration Number: NCT04254250
• Lead Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-01
• Study First Submitted QC: 2020-02-01
• Study First Posted: 2020-02-05
• Study Start: 2020-02-10
• Primary Completion: 2023-08-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 386

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk recurrence group	Preoperative risk estimation of disc herniation recurrence	Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.
Low risk recurrence group	Preoperative risk estimation of disc herniation recurrence	Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.

Primary Outcome Measures

Name	Time	Method
Reherniation rate	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 Outcome Measures

Name	Time	Method
Improvement of Oswestry Disability Index (ODI)	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).
Change from baseline in EQ-5D (EuroQl - 5 dimensional)	6, 12, 18, 24, 30, 36 months follow up	To observe change in EQ-5Dl as compared to baseline
Improvement of Visual analog scale (VAS) leg pain intensity	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.
HTI Item (from SF-36)	6, 12, 18, 24, 30, 36 months follow up	To observe the HTI Item (from SF-36) as compared to baseline

Trial Locations

Locations (2)

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan; 🇷🇺 Novosibirsk, Russian Federation

Priorov National Medical Research Center of Traumatology and Orthopedics; 🇷🇺 Moscow, Russian Federation