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
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
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.
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
NCT ID
NCT05584774
First Posted
October 6, 2022
Last Updated
November 24, 2022
Sponsor
Ramathibodi Hospital
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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