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

Intervertebral Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04254250
• Other study ID #: NS02-03
• Status: Active, not recruiting
• Start date: February 10, 2020
• Est. completion date: February 10, 2026

Study information

• Verified date: October 2023
• Source: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 386
• Est. completion date: February 10, 2026
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Intervertebral Disc Herniation
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Priorov National Medical Research Center of Traumatology and Orthopedics	Moscow
Russian Federation	Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan	Novosibirsk

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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