Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Procedure: microendoscopic discectomy; Procedure: transforaminal endoscopic lumbar discectomy; Procedure: open discectomy

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wang Kun, PHD; Phone Number: +86(25)-83262331; Email: wangkunspine@163.com
• Study Contact Backup: Name: Wu Xiaotao, MD; Phone Number: +86(25)-83262331; Email: wuxiaotao@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: open discectomy; patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)	Procedure: microendoscopic discectomy; Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.; Procedure: transforaminal endoscopic lumbar discectomy; transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen
Active Comparator: microendoscopic discectomy; patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)	Procedure: transforaminal endoscopic lumbar discectomy; transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen; Procedure: open discectomy; The open discectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.
Active Comparator: transforaminal endoscopic discectomy; patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)	Procedure: microendoscopic discectomy; Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.; Procedure: open discectomy; The open discectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index(ODI)	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	up to 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale(VAS)	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	up to 104 weeks
The generic health survey on the Short Form-36(SF-36)	The scale was used to evaluate the quality of life	up to 104 weeks
Complications survey	Complications of surgery including mortality and common: thrombosis; surgical site and other infections; recurrent disc herniation; dural tear; nerve root injury	up to 104 weeks

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Wu Xiaotao, MD, Zhangda hospital,Southeast university

Publications and helpful links

General Publications

• Liu WG, Wu XT, Guo JH, Zhuang SY, Teng GJ. Long-term outcomes of patients with lumbar disc herniation treated with percutaneous discectomy: comparative study with microendoscopic discectomy. Cardiovasc Intervent Radiol. 2010 Aug;33(4):780-6. doi: 10.1007/s00270-009-9720-6. Epub 2009 Oct 15.
• Wu X, Zhuang S, Mao Z, Chen H. Microendoscopic discectomy for lumbar disc herniation: surgical technique and outcome in 873 consecutive cases. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2689-94. doi: 10.1097/01.brs.0000244615.43199.07.

Helpful Links

• The North American Spine Society

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: WANG-8808-KUN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No