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

Study Overview
=================
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.

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

Conditions
-----------------
Intervertebral Disc Herniation

Intervention / Treatment
-----------------
* Diagnostic Test: Preoperative risk estimation of disc herniation recurrence


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk recurrence group<br>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<br>* 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.<br>|
| Low risk recurrence group<br>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<br>* 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.<br>|

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 |