Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-12-30

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.

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Detailed Description

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Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PELD

Group Type PLACEBO_COMPARATOR

PELDAN

Intervention Type PROCEDURE

percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

PELD and annuloplasty and nucleoplasty

Group Type ACTIVE_COMPARATOR

PELDAN

Intervention Type PROCEDURE

percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

Interventions

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PELDAN

percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No