Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy

Joimax GmbH

Overview

This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed. The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Lumbar Disc Herniation

Interventions

joimax TESSYSPROCEDURE

Transforaminal Endoscopic Surgery System

MicrodiscectomyPROCEDURE

Standard procedure for disc surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic lumbar disc herniation * clinical and radiological evidence of nerve root compression * failure of conservative treatment for at least 6 weeks Exclusion Criteria: * previous lumbar spine surgery * severe or progressive motor deficit * BMI \> 40 * cauda equina syndrome

Locations (3)

University Clinic of Neurosurgery

Graz, Austria

Ligamenta Spine Center

Frankfurt, Germany

University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology

Heidelberg, Germany

Outcomes

Primary Outcomes

Change from baseline in Oswestry Disability Index at 4 years

Time frame: total follow-up period of 4 years

Secondary Outcomes

Change from baseline in Quality of Life (SF-12)

Time frame: total follow-up period of 4 years

Health resources consumption

Time frame: total follow-up period of 4 years

Complication rate

Time frame: 2 years

Patient satisfaction

Time frame: Total follow-up period of 4 years

Change from baseline in back and leg pain (NRS)

Time frame: total follow-up period of 4 years

Data from ClinicalTrials.gov

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