Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

Southeast University, China

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lumbar Disc Herniation

Treatments: Procedure: microendoscopic discectomy; Procedure: open discectomy; Procedure: transforaminal endoscopic lumbar discectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02358291

WANG-8808-KUN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups

open discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: microendoscopic discectomy

Procedure: transforaminal endoscopic lumbar discectomy

microendoscopic discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: open discectomy

Procedure: transforaminal endoscopic lumbar discectomy

transforaminal endoscopic discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: microendoscopic discectomy

Procedure: open discectomy