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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.
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) and microendoscopic discectomy (MED) are two widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. As difference in operative approaches and iatrogenic injury, the clinical outcome might be dramatically different from each other.
In this study, a single center randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic LDH. We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.
Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PTED, and 2) patients diagnosed with lumbar disc herniation undergoing MED.
The primary outcomes of the study will be score of Oswestry Disability Index (ODI) as measured at pre- and post-operation, 1 month, 3 months, 6 months, and annually thereafter. Secondary outcomes include Visual Analog Scale (VAS), the SF-36 Health Survey, as well as post-operative radiological assessment. Treatment effect is defined as the difference in the mean change from baseline between the two groups. Lumbar intervertebral disc tissue would be obtained during surgery for histological analysis, in order to evaluate disc degeneration and find out risk factors of it.
On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of PTED versus MED for minimal invasive surgical treatment for symptomatic lumbar disc herniation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transforaminal discectomy | Active Comparator | patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED). |
|
| Microendoscopic discectomy | Active Comparator | Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous transforaminal endoscopic discectomy (PTED) | Procedure | Percutaneous transforaminal endoscopic discectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Limin Rong, M.D. | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36114871 | Derived | 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. | |
| 36083850 | 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. |
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| Microendoscopic discectomy (MED) | Procedure | Microendoscopic discectomy |
|
| postoperation |
| 35378590 | 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. |
| 29303469 | 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. |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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