Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation

NCT01997086 | Unknown Phase 4 DMC

• 1 other identifier: PTED-MED
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic lumbar disc herniation.

Conditions

Lumbar Herniated Disc

Outcome Measures

Primary Outcomes (1)

• Changes in pain and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI)

  Baseline, post-operation, 1 month, 3 months, 6 months, and annually thereafter

Secondary Outcomes (2)

• Changes in health-related quality of life as measured by the EQ-5D,Visual Analog Scale (VAS) and the SF-36 health status questionnaire, and the radiological changes in spine as measured by x-ray, CT or MRI.

  Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter.

• Histological analysis of surgical lumbar intervertebral disc tissue

  postoperation

Study Arms (2)

Transforaminal discectomy

ACTIVE COMPARATOR

patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED).

Procedure: Percutaneous transforaminal endoscopic discectomy (PTED)

Microendoscopic discectomy

ACTIVE COMPARATOR

Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED).

Procedure: Microendoscopic discectomy (MED)

Interventions

Percutaneous transforaminal endoscopic discectomy (PTED) PROCEDURE

Percutaneous transforaminal endoscopic discectomy

Transforaminal discectomy

Microendoscopic discectomy (MED) PROCEDURE

Microendoscopic discectomy

Microendoscopic discectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent radicular pain.
• Signs including evidence of nerve root compression with a positive nerve root tension sign (straight leg raising test or femoral tension sign) or a corresponding sign of neurological deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution).
• An imaging study (MRI or CT) showing LDH at a level and side corresponding to the patients radicular signs or symptoms.

You may not qualify if:

• \<18 or \>65 years of age
• Insufficient conservative treatment (6 weeks)
• Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
• Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
• Equal to or more than two responsible level
• High-grade migrated disc herniation
• Previous spinal surgery
• Possible pregnancy or other comorbid conditions contraindicating surgery

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (4)

• Chen Z, He L, Di J, Huang L, Feng F, Yang B, Xie P, Rong L. Lumbar facet joint osteoarthritis as the underlying reason for persistent low back pain after minimally invasive discectomy. Arch Orthop Trauma Surg. 2023 Jul;143(7):3811-3821. doi: 10.1007/s00402-022-04595-y. Epub 2022 Sep 17.

  PMID: 36114871 DERIVED

• Chen Z, Zhang L, Dong J, Xie P, Liu B, Chen R, Li S, Liu Z, Yang B, Feng F, He L, Yang Y, Pang M, Rong L. Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disk Herniation: Five-year Results of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2023 Jan 15;48(2):79-88. doi: 10.1097/BRS.0000000000004468. Epub 2022 Sep 7.

  PMID: 36083850 DERIVED

• Chen Z, He L, Huang L, Liu Z, Dong J, Liu B, Chen R, Zhang L, Xie P, Rong L. Risk Factors for Poor Outcomes Following Minimally Invasive Discectomy: A Post Hoc Subgroup Analysis of 2-Year Follow-up Prospective Data. Neurospine. 2022 Mar;19(1):224-235. doi: 10.14245/ns.2143084.542. Epub 2022 Mar 31.

  PMID: 35378590 DERIVED

• Chen Z, Zhang L, Dong J, Xie P, Liu B, Wang Q, Chen R, Feng F, Yang B, Shu T, Li S, Yang Y, He L, Pang M, Rong L. Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation: 1-year results of an ongoing randomized controlled trial. J Neurosurg Spine. 2018 Mar;28(3):300-310. doi: 10.3171/2017.7.SPINE161434. Epub 2018 Jan 5.

  PMID: 29303469 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Limin Rong, M.D.

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., M.D.

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

CN (1)