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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

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006057
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 6
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID HC20C0163
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University Medical Center-Kangnam
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M48.06)Spinal stenosis, lumbar region 

    Spinal stenosis
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2025. 12
    Way of Sharing To be made available at a later date
    (phjfrog@hanmail.net)
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