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

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

Status: Active, not recruiting

Conditions: Intervertebral Disc Herniation

Treatments: Diagnostic Test: Preoperative risk estimation of disc herniation recurrence

Study type: Observational

Funder types: Other

Identifiers

NCT04254250

NS02-03

Details and patient eligibility

About

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.

Enrollment: 386 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

386 participants in 2 patient groups

High risk recurrence group

Description:

Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.

Treatment:

Diagnostic Test: Preoperative risk estimation of disc herniation recurrence

Low risk recurrence group

Description:

Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.

Treatment:

Diagnostic Test: Preoperative risk estimation of disc herniation recurrence