NCT04855682

EuroPainClinicsStudy X

EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: EPC Education s.r.o. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

Detailed description

The aim of this clinical study is to compare the benefits and complications after minimally invasive spinal procedures in patients with acute lumbosacral radicular syndrome caused by a herniated disc compressing the spinal neural structures. The study only works with patient data provided by the outpatient clinic for research analysis in the EPCS IV clinical study. All patient data are encrypted during collection and evaluation during the study, and stored in an encrypted database. The data will be evaluated by an independent institution - The Institute of Measurement of the Slovak Academy of Sciences.

Conditions

• Back Pain

Interventions

Type	Name	Description
OTHER	Retrospective observation after 24 months after the spinal procedure	Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
OTHER	Retrospective observation after 12 months after the spinal procedure	Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
OTHER	Prospective evaluation of patients after 12 and 24 months after the spinal procedure	Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-04-15
• Completion: 2024-04-15
• First posted: 2021-04-22
• Last updated: 2021-05-26

Locations

3 sites across 1 country: Slovakia