Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Outcomes of Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty for Lumbar Disc Herniation: Randomized Controlled Trial

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Procedure: PELDAN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PELD<br> | Procedure: PELDAN<br>* percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty<br>|
| Active Comparator: PELD and annuloplasty and nucleoplasty<br> | Procedure: PELDAN<br>* percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS back pain |  | 48 weeks | 
| VAS leg pain |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI | Oswestry disability index | 48 weeks | 
| complications | Nerve injury, foot drop, dura tear | 48 weeks | 
| re-operation |  | 48 weeks |