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Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Primary Purpose

Lumbar Disc Herniation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PELDAN
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary single-level lumbosacral intervertebral disc herniation at the L4-L5 or L5- S1 level will perform surgical intervention of percutaneous endoscopic lumbar discectomy
  • All patients present with sciatica and back pain that will not improve with conservative treatment for a minimum of 6 weeks
  • All patients undergo plain radiographs, magnetic resonance imaging (MRI)
  • The patients will require to have an obvious disc herniation that caused compression of a nerve root corresponding to the dermatomal distribution of the leg symptoms.

Exclusion Criteria:

  • Patients have foraminal, extra-disc herniation, multilevel disc herniation, spinal stenosis, spondylolisthesis, scoliosis, prior lumbar surgery, spinal infection, spinal tumor, and a history of hip or knee arthritis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    PELD

    PELD and annuloplasty and nucleoplasty

    Arm Description

    Outcomes

    Primary Outcome Measures

    VAS back pain
    VAS leg pain

    Secondary Outcome Measures

    ODI
    Oswestry disability index
    complications
    Nerve injury, foot drop, dura tear
    re-operation

    Full Information

    First Posted
    October 6, 2022
    Last Updated
    November 24, 2022
    Sponsor
    Ramathibodi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05584774
    Brief Title
    Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty
    Official Title
    Clinical Outcomes of Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty for Lumbar Disc Herniation: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ramathibodi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Recently, percutaneous endoscopic lumbar discectomy (PELD) is also commonly performed for lumbar disc herniation. Following discectomy, the relief of leg pain is common; however, the relief of back pain is less predictable. The association of back pain and lumbar disc herniation is still unclear. PELD and Annuloplasty (PELDA) can relieve back pain associated with disc herniation as well as leg pain through decompression and thermal ablation of annular defects in selected patients. Another problem that rapidly increasing go along with the growing number of microdiscectomies is directly proportional to the number of patients who undergo re-operations due to recurrences. The surgical treatment can be helpful in prevention of re-operations is nucleoplasty. Endoscopic discectomy for lumbosacral herniation supplemented with nucleoplasty can reduce the recurrence and reoperation rates.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PELD
    Arm Type
    Placebo Comparator
    Arm Title
    PELD and annuloplasty and nucleoplasty
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    PELDAN
    Intervention Description
    percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty
    Primary Outcome Measure Information:
    Title
    VAS back pain
    Time Frame
    48 weeks
    Title
    VAS leg pain
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    ODI
    Description
    Oswestry disability index
    Time Frame
    48 weeks
    Title
    complications
    Description
    Nerve injury, foot drop, dura tear
    Time Frame
    48 weeks
    Title
    re-operation
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary single-level lumbosacral intervertebral disc herniation at the L4-L5 or L5- S1 level will perform surgical intervention of percutaneous endoscopic lumbar discectomy All patients present with sciatica and back pain that will not improve with conservative treatment for a minimum of 6 weeks All patients undergo plain radiographs, magnetic resonance imaging (MRI) The patients will require to have an obvious disc herniation that caused compression of a nerve root corresponding to the dermatomal distribution of the leg symptoms. Exclusion Criteria: Patients have foraminal, extra-disc herniation, multilevel disc herniation, spinal stenosis, spondylolisthesis, scoliosis, prior lumbar surgery, spinal infection, spinal tumor, and a history of hip or knee arthritis.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

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