Status Approved
First Submitted Date
2021/03/17
Registered Date
2021/04/05
Last Updated Date
2022/02/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006057 |
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Unique Protocol ID | HC20C0163 |
Public/Brief Title | Evaluation of the efficacy and safety of biportal endoscopic decompressive laminectomy to treat lumbar spinal stenosis |
Scientific Title | Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-B Trial): A prospective, randomized, Assessor blind, multicenter trial |
Acronym | ENDO-BS Trial |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | HKS2021-02-022-002 |
Approval Date | 2021-03-09 |
Institutional Review Board Name | Hallym University Kangnam Sacred Heart Hospital Institutional Review Board |
Institutional Review Board Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul |
Institutional Review Board Telephone | 02-829-5527 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hyun-Jin Park |
Title | Assistant Professor |
Telephone | +82-2-9028-2839 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Ki-Han You |
Title | Fellow |
Telephone | +82-2-9979-8735 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | MINJI KIM |
Title | CRC |
Telephone | +82-2-2619-7432 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea |
4. Status
Study Site | Multi-center Number of center : 6 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-19 Actual | |
Target Number of Participant | 120 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hallym University Medical Center-Kangnam | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-19 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Korea University Anam Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-03-02 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Medical Corporation Thomas Medical Foundation WILTSE MEMORIAL HOSPITAL | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-01-18 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | Bumin Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-01-27 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | Seoul National University Bundang Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-27 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Chung-Ang Univerisity Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-22 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HC20C0163 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University Medical Center-Kangnam |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Posterior decompression in lumbar stenosis and posterior access discectomy in lumbar disc herniation are the most conventional methods used to resolve the patient's symptoms. Existing conventional methods involve a lot of bleeding, postoperative pain, instability, injury of paraspinal muscles, and other problems, so minimally invasive surgery is performed to preserve the anatomical structure. As a representative method of minimally invasive surgery, the unilateral laminectomy bilateral decompression (ULBD) is the most widely used, and the method through the supine incision and the method using an endoscope are used. Minimally invasive surgery has many advantages over existing conventional methods, and clinical results are reported to be no different from conventional methods. The method using the existing uniportal endoscope has many advantages, but the field of view is narrow, the operation time is long, and problems such as insufficient decompression may occur. Recently, endoscopic decompression and discectomy have been developed and used. Endoscopic spinal surgery is divided into uniportal endoscopic surgery and biportal endoscopic surgery according to the number of open holes into which the instrument is inserted. Since the surgical site is accessed through a skin incision within 1cm, damage to the normal structure can be minimized, so there are fewer complications such as pain and nerve adhesions after surgery. In addition, since instruments for knee joint and shoulder joint arthroscopic surgery can be used, there is little need to purchase additional equipment, and it has the advantage of being able to use familiar instruments. However, endoscopic spinal surgery has been reported to have good clinical results as a retrospective study, but the clinical results have not yet been confirmed in a multicenter, prospective, randomized study. In addition, conventional surgery and microscopic surgery currently performed in patients with lumbar stenosis are recognized as insurance benefits and are appropriately used for patients in need of surgery, whereas spinal endoscopic surgery has not yet been properly recognized in Korea, so limited practice in patients only some disc herniation. Most of the spinal endoscopic surgery studies reported in Korea are retrospective studies, and Level 1 studies to establish the effectiveness and stability of endoscopic surgery compared to conventional surgery are insufficient. Therefore, in this study, we would like to compare the efficacy and stability of endoscopic surgery with the clinical results of conventional posterior decompression with established clinical results through a multicenter prospective randomized study. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject, Outcome Accessor |
Allocation | RCT |
Intervention Type | /Procedure/Surgery |
Intervention Description | (1) Biportal Endoscopic Spine Surgery Posterior Decompression Posterior decompression is performed using arthroscopic instruments and spinal surgery instruments. Since two instruments can be inserted, it is called biportal spinal endoscopic posterior decompression, and an incision can be inserted only where the portal enters, thus minimizing damage to normal tissue. After disinfecting the surgical site, create a viewing portal for entry into the endoscopic camera and continuous perfusion, and a working portal for insertion of instruments for decompression. Make one portal at the height of the upper boundary of the transverse process, 1 cm outside of the lateral boundary of the upper vertebrae, and a second entrance at the distal of about 2 cm. For continuous saline drainage and instrument insertion, a skin incision approximately 1 cm long is sufficient for each insertion port. At the operator's position, the left side is used as the work insertion port, and the right side is the observation port for sight. In the intervertebral cavity, the proximal portion of the yellow ligament is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing yellow ligamentectomy in the target compartment, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. After performing yellow ligament resection, paying attention to the damage to the nerve roots, check whether the nerve roots are free to run. In addition, if the angle of the endoscope camera is tilted toward the operator, the posterior arch can be viewed from the neuromuscular side, and further entering the camera in this state can also check the neuromuscular on the other side. As well as a camera, surgical instruments can be accessed through the right side of the operation opening, so that some of the structures (bone structures such as the yellow ligament and the posterior arch) that are compressing the nerve roots can be removed to perform posterior decompression. When posterior decompression is performed, it can be confirmed with a camera that the nerve roots become more free than before. Stop bleeding at the surgical site, remove the endoscopic camera and surgical instruments, suture and disinfect the surgical site, and complete the operation. (2) Conventional Posterior Laminectomy It is a method of removing thickened yellow ligaments on both sides by inserting a mid line incision and approaching both sides openly. Currently, it is a universal laminectomy method. After disinfecting the surgical site, check the surgical site with simple lumbar locating radiography. A skin incision is made about 3 cm long from the midline of the surgery site to the long axis, and enough visibility can be secured. The lateral muscle of the spine is detached from the sphincter, the posterior arch and the vertebral joint, and the fascia flap is tilted, and the surgical field of view is secured using a retractor. In the intervertebral cavity, the proximal portion of the yellow ligament is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing flavectomy in the target compartment, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. During yellow ligament resection, the lower part of the posterior condylar bone of the upper spine and the upper part of the posterior condyle bone of the lower vertebrae are carefully removed to ensure additional decompression and visibility. At this time, care should be taken not to damage the posterior joint. Afterwards, the nerve roots are checked, and the decompression is performed. After that, hemostasis is performed on the surgical site, sutures and disinfection of the surgical site is performed, and the operation is completed. |
Number of Arms | 2 |
Arm 1 |
Arm Label Biportal Endoscopic Spine Surgery Posterior Decompression |
Target Number of Participant 60 |
|
Arm Type Experimental |
|
Arm Description Posterior decompression is performed using arthroscopic instruments and spinal surgery instruments. Since two instruments can be inserted, it is called biportal spinal endoscopic posterior decompression, and an incision can be inserted only where the portal enters, thus minimizing damage to normal tissue. After disinfecting the surgical site, create a viewing portal for entry into the endoscopic camera and continuous perfusion, and a working portal to insert instruments for decompression. Make one portal at the height of the upper boundary of the transverse process, 1 cm outside of the lateral boundary of the upper vertebrae, and a second entrance at the distal of about 2 cm. For continuous saline drainage and instrument insertion, a skin incision approximately 1 cm long is sufficient for each insertion port. At the operator's position, the left side is used as the work insertion port, and the right side is the observation port for sight. In the intervertebral cavity, the proximal portion of the yellow ligament is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing yellow ligamentectomy in the target compartment, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. After performing yellow ligament resection, paying attention to nerve root damage, check whether the nerve root is free to run. In addition, if the angle of the endoscope camera is tilted toward the operator, the posterior arch can be viewed from the nerve root, and if the camera is further entered in this state, the nerve root on the opposite side can also be checked. In addition to the camera, surgical instruments can be accessed through the right side of the operation insertion port, so that some structures (bone structures such as the yellow ligament and the posterior arch) that are compressing the nerve roots can be removed to perform posterior decompression. When posterior decompression surgery is performed, it can be confirmed with a camera that the nerve roots become more free than before the surgery. After hemostasis at the surgical site, the endoscope camera and surgical instruments are removed, the surgical site is sutured and disinfected, and the operation is completed. |
|
Arm 2 |
Arm Label Conventional Posterior Laminectomy |
Target Number of Participant 60 |
|
Arm Type Active comparator |
|
Arm Description It is a method of removing thickened yellow ligaments on both sides by inserting a mid line incision and approaching both sides openly. Currently, it is a universal laminectomy method. After disinfecting the surgical site, check the surgical site with simple lumbar locating radiography. A skin incision is made about 3 cm long from the midline of the surgery site to the long axis, and enough visibility can be secured. The lateral muscle of the spine is detached from the sphincter, the posterior arch and the vertebral joint, and the fascia flap is tilted, and the surgical field of view is secured using a retractor. In the intervertebral cavity, the proximal portion of the yellow ligament is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing yellow ligamentectomy in the target compartment, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. During yellow ligament resection, the lower part of the posterior condylar bone of the upper spine and the upper part of the posterior condyle bone of the lower vertebrae are carefully removed to ensure additional decompression and visibility. At this time, care should be taken not to damage the posterior joint. Afterwards, the nerve roots are checked, and the decompression is performed by confirming the nerve movement to the proximal portion of the pedicle of the lower spine to sufficiently decompress to the distal end along the driving of the nerve root. After performing decompression in the same way on the other side, check if both nerve roots are free to run. After that, hemostasis is performed on the surgical site, sutures and disinfection of the surgical site is performed, and the operation is completed. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region Spinal stenosis |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~80Year |
|
Description A. 20 to 80 years old B. Those who have a grade of B or higher for lumbar central canal stenosis and who choose to perform 1-2 segment posterior decompression C. Those who can follow up for more than 1 year D. Research subject who signed the consent form after fully understanding the contents of the clinical trial by the principal (if signature is possible) |
|
Exclusion Criteria |
A. Meyer Gr II or higher spondylolisthesis B. Those who have previously performed the same segmental surgery C. Lumbar degenerative scoliosis (Cobb angle> 20 degrees) D. If the cause of the stenosis is not degenerative or due to an intervertebral disc herniation E. If there is another spinal disease in the affected area of lumbar stenosis (ankylosing spondylitis, tumor, compression fracture, etc.) F. Psychiatric diseases (dementia, mental retardation, severe drug addiction, etc.) G. Those who refused to participate in the study H. Other patients who are in charge of clinical trials as unsuitable for clinical trials |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Oswestry Disability Index (ODI) |
|
Timepoint | Postoperative 1year |
|
Secondary Outcome(s) 1 | ||
Outcome | Visual Analogue Scale (VAS) |
|
Timepoint | Postoperative 1year |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2025. 12 |
Way of Sharing | To be made available at a later date
(phjfrog@hanmail.net) |
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