NCT04254250

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 386 (actual)
• Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intervertebral Disc Herniation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-10
• Primary completion: 2023-08-10
• Completion: 2026-02-25
• First posted: 2020-02-05
• Last updated: 2026-02-27

Locations

2 sites across 1 country: Russia