Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

Lumbar Disc Herniation Clinical Trial

Official title: Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation

Status Not yet recruiting

Clinical Trial Summary

In our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation.

Clinical Trial Description

Lumbar disc herniation (LDH) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. In spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable number of invalid patients who eventually still need to be undergoing a surgical operation treatment. Three main methods for intervertebral disc surgery are adopted in our routine work. One procedure is Open Discectomy (OD), which has been always a gold standard for treatment of LDH. And the other two procedures are Microendoscopic Discectomy (MED) and Transforaminal Endoscopic Lumbar Discectomy (TELD) respectively. MED and TELD have been developed as alternatives to OD. OD can compress the nerve root or spinal cord through removal of the protrusion. However, it destroys the rear structure of spine, causing segmental instability and long-term distress. Compared with OD, MED and TELD procedures are smaller incisions or less dissection (or both), lower blood loss, less postoperative pain, shorter hospitalisation and earlier return to work. However, the steep learning curves of MID inhibit the development of surgery specialists; for example, optimal surgical management requires many years of experience. These deficiencies need more educational effort at a higher priority than accorded so far. There are inconsistent outcomes about the efficacy and safety in the previous studies; all of the recent researches do not yield conclusive results. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

• NCT number: NCT02358291
• Study type: Interventional
• Source: Southeast University, China
• Contact: Wang Kun, PHD
• Phone: +86(25)-83262331
• Email: wangkunspine@163.com
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Completion date: March 2017