Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

NCT05584774 | Unknown

• 1 other identifier: NO40/2565
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

• VAS back pain

  48 weeks

• VAS leg pain

  48 weeks

Secondary Outcomes (3)

• ODI

  48 weeks

• complications

  48 weeks

• re-operation

  48 weeks

Study Arms (2)

PELD

PLACEBO COMPARATOR

Procedure: PELDAN

PELD and annuloplasty and nucleoplasty

ACTIVE COMPARATOR

Procedure: PELDAN

Interventions

PELDAN PROCEDURE

percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

PELD; PELD and annuloplasty and nucleoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramathibodi Hospital: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 18, 2022
• Study Start: November 30, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share