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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02358291
• Other study ID #: WANG-8808-KUN
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 26, 2015
• Last updated: February 6, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2015
• Source: Southeast University, China
• Contact: Wang Kun, PHD
• Phone: +86(25)-83262331
• Email: wangkunspine[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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, ?°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

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

Intervention

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.
• 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.
• transforaminal endoscopic lumbar discectomy
transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

References & Publications (2)

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   The North American Spine Society