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

Joimax

Status: Withdrawn

Conditions: Lumbar Disc Herniation

Treatments: Procedure: Microdiscectomy; Procedure: joimax TESSYS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01622413

2011/001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Endscopy

Experimental group

Treatment:

Procedure: joimax TESSYS

Microsurgery

Active Comparator group

Treatment:

Procedure: Microdiscectomy