Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation

Lumbar Herniated Disc Clinical Trial

Official title:

Percutaneous Transforaminal Endoscopic Discectomy (PTED) Versus Microendoscopic Discectomy (MED) for the Treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01997086
• Other study ID #: PTED-MED
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 14, 2013
• Last updated: April 19, 2017
• Start date: October 2013
• Est. completion date: August 2023

Study information

• Verified date: April 2017
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic lumbar disc herniation.

Description:

Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) and microendoscopic discectomy (MED) are two widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. As difference in operative approaches and iatrogenic injury, the clinical outcome might be dramatically different from each other.

In this study, a single center randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic LDH. We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.

Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PTED, and 2) patients diagnosed with lumbar disc herniation undergoing MED.

The primary outcomes of the study will be score of Oswestry Disability Index (ODI) as measured at pre- and post-operation, 1 month, 3 months, 6 months, and annually thereafter. Secondary outcomes include Visual Analog Scale (VAS), the SF-36 Health Survey, as well as post-operative radiological assessment. Treatment effect is defined as the difference in the mean change from baseline between the two groups. Lumbar intervertebral disc tissue would be obtained during surgery for histological analysis, in order to evaluate disc degeneration and find out risk factors of it.

On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of PTED versus MED for minimal invasive surgical treatment for symptomatic lumbar disc herniation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Persistent radicular pain.

• Signs including evidence of nerve root compression with a positive nerve root tension sign (straight leg raising test or femoral tension sign) or a corresponding sign of neurological deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution).

• An imaging study (MRI or CT) showing LDH at a level and side corresponding to the patients radicular signs or symptoms.

Exclusion Criteria:

• <18 or >65 years of age

• Insufficient conservative treatment (6 weeks)

• Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention

• Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)

• Equal to or more than two responsible level

• High-grade migrated disc herniation

• Previous spinal surgery

• Possible pregnancy or other comorbid conditions contraindicating surgery

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Herniated Disc

Intervention

Procedure:
• Percutaneous transforaminal endoscopic discectomy (PTED)
Percutaneous transforaminal endoscopic discectomy
• Microendoscopic discectomy (MED)
Microendoscopic discectomy

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI)		Baseline, post-operation, 1 month, 3 months, 6 months, and annually thereafter
Secondary	Changes in health-related quality of life as measured by the EQ-5D,Visual Analog Scale (VAS) and the SF-36 health status questionnaire, and the radiological changes in spine as measured by x-ray, CT or MRI.		Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter.
Secondary	Histological analysis of surgical lumbar intervertebral disc tissue		postoperation