Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

NCT ID: NCT02358291

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

open discectomy

patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)

Group Type: ACTIVE_COMPARATOR

microendoscopic discectomy

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

microendoscopic discectomy

patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)

Group Type: ACTIVE_COMPARATOR

open discectomy

Intervention Type: PROCEDURE

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.

transforaminal endoscopic lumbar discectomy

Intervention Type: PROCEDURE

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

transforaminal endoscopic discectomy

patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)

Group Type: ACTIVE_COMPARATOR

open discectomy

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

transforaminal endoscopic lumbar discectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Kun Wang

Kun Wang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Xiaotao, MD

Role: STUDY_DIRECTOR

Zhangda hospital,Southeast university

Central Contacts

Wang Kun, PHD

Role: CONTACT

wangkunspine@163.com

+86(25)-83262331

Wu Xiaotao, MD

Role: CONTACT

wuxiaotao@medmail.com.cn

+86(25)-83262331

References

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.

Reference Type: RESULT

PMID: 19830485 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17077737 (View on PubMed)

Other Identifiers

WANG-8808-KUN

Identifier Type: -

Identifier Source: org_study_id