| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
Experimental: Biportal endoscopic discectomy
Biportal endoscopic discectomy for lumbar herniated intervertebral disc
|
Procedure: Biportal endoscopy
Biportal endoscopic spine surgery (BESS)
|
|
Active Comparator: Microdiscectomy
Microdiscectomy for lumbar herniated intervertebral disc
|
Procedure: Microdiscectomy
Using microscope for discectomy
|
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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| 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 |
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