Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

Phase 1

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: microendoscopic discectomy; Procedure: open discectomy; Procedure: transforaminal endoscopic lumbar discectomy

• Registration Number: NCT02358291
• Lead Sponsor: Southeast University, China

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2015-01-26
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09
• Study Start: 2015-03
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. All forms of disc herniation were included in the study
2. History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months
3. Leg pain must be greater than back pain

Exclusion Criteria

1. cauda equine syndrome,
2. progressive neurologic deficit,
3. bilateral lower extremity symptoms,
4. low back pain more than leg pain
5. Systemic infection or localized infection at the anticipated entry needle site
6. combined with lumbar infection, fracture of lumbar vertebra, tumor, Ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree
7. with severe heart, brain, lungs, and other organs disease or mental illness
8. History of opioid abuse or patients currently on long acting opioid
9. History of the operation on lumbar
10. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open discectomy	microendoscopic discectomy	patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)
microendoscopic discectomy	transforaminal endoscopic lumbar discectomy	patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)
open discectomy	transforaminal endoscopic lumbar discectomy	patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)
transforaminal endoscopic discectomy	microendoscopic discectomy	patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)
microendoscopic discectomy	open discectomy	patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)
transforaminal endoscopic discectomy	open discectomy	patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index(ODI)	up to 104 weeks	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome

Secondary Outcome Measures

Name	Time	Method
visual analogue scale(VAS)	up to 104 weeks	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome
The generic health survey on the Short Form-36(SF-36)	up to 104 weeks	The scale was used to evaluate the quality of life
Complications survey	up to 104 weeks	Complications of surgery including mortality and common: thrombosis; surgical site and other infections; recurrent disc herniation; dural tear; nerve root injury