Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Not Applicable

Not yet recruiting

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: PELDAN

• Registration Number: NCT05584774
• Lead Sponsor: Ramathibodi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28
• Study Start: 2022-11-30
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PELD	PELDAN	-
PELD and annuloplasty and nucleoplasty	PELDAN	-

Primary Outcome Measures

Name	Time	Method
VAS back pain	48 weeks
VAS leg pain	48 weeks

Secondary Outcome Measures

Name	Time	Method
re-operation	48 weeks
ODI	48 weeks	Oswestry disability index
complications	48 weeks	Nerve injury, foot drop, dura tear