NCT01997086|UnknownPhase 4DMC
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Sponsor study identifier
interventional
125
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 14, 2013
Actual (reported)November 27, 2013
Actual (reported)August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED).
Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED).
Percutaneous transforaminal endoscopic discectomy
Microendoscopic discectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
He T, Li S, Huang L, Dong J, He L, Liu Z, Chen Z. Prevalence and clinical relevance of endplate junction failure in lumbar disc herniation: a post-hoc subgroup analysis of 5-year follow-up prospective data. Eur Spine J. 2026 Aug 7. doi: 10.1007/s00586-026-10270-2. Online ahead of print.
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.
Limin Rong, M.D.
Third Affiliated Hospital, Sun Yat-Sen University
First Submitted
November 14, 2013
First Posted
November 27, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2023
Contact the study team to confirm eligibility.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 20, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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