Condition or disease | Intervention/treatment | Phase |
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Lumbar Herniated Intervertebral Disc | Procedure: Biportal endoscopy Procedure: Microdiscectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial |
Actual Study Start Date : | May 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: Biportal endoscopic discectomy
Biportal endoscopic discectomy for lumbar herniated intervertebral disc
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Procedure: Biportal endoscopy
Biportal endoscopic spine surgery (BESS)
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Active Comparator: Microdiscectomy
Microdiscectomy for lumbar herniated intervertebral disc
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Procedure: Microdiscectomy
Using microscope for discectomy
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The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
This is assessed by ODI survey at 1 year after surgery
Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sang-Min Park, M.D. | 82-31-787-7810 | psmini@snubh.org |
Korea, Republic of | |
Seoul National University Bundang Hospital | Recruiting |
Seongnam-si, Gyounggido, Korea, Republic of | |
Contact: Sang-Min Park, M.D. psmini@naver.com | |
Sub-Investigator: Jin S. Yeom, M.D. | |
Principal Investigator: Sang-Min Park, M.D. | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of, 35015 | |
Contact: Ho-Jin Lee, M.D. 82-42-280-7345 leeleo98@gmail.com | |
Principal Investigator: Ho-Jin Lee, M.D |
Tracking Information | |||||
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First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | April 23, 2019 | ||||
Last Update Posted Date | October 22, 2020 | ||||
Actual Study Start Date ICMJE | May 1, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Oswestry disability index (ODI) [ Time Frame: at 1 year after surgery ] The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
This is assessed by ODI survey at 1 year after surgery
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial | ||||
Official Title ICMJE | Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial | ||||
Brief Summary | This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Lumbar Herniated Intervertebral Disc | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03924700 | ||||
Other Study ID Numbers ICMJE | BESS_002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Jin S. Yeom, Seoul National University Hospital | ||||
Study Sponsor ICMJE | Seoul National University Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Seoul National University Hospital | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |