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Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

M

Mahidol University

Status

Not yet enrolling

Conditions

Lumbar Disc Herniation

Treatments

Procedure: PELDAN

Study type

Interventional

Funder types

Other

Identifiers

NCT05584774
NO40/2565

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups, including a placebo group

PELD
Placebo Comparator group
Treatment:
Procedure: PELDAN
PELD and annuloplasty and nucleoplasty
Active Comparator group
Treatment:
Procedure: PELDAN

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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