Clinical trial NCT02358291: Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
Official title: Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lumbar Disc Herniation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry Disability Index(ODI)
timeFrame: up to 104 weeks
Secondary outcomes:
measure: visual analogue scale(VAS)
timeFrame: up to 104 weeks
measure: The generic health survey on the Short Form-36(SF-36)
timeFrame: up to 104 weeks
measure: Complications survey
timeFrame: up to 104 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Zhangda hospital,Southeast university
name: Wu Xiaotao, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1097/01.brs.0000244615.43199.07.