Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05584774
• Other study ID #: NO40/2565
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• PELDAN
percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS back pain		48 weeks
Primary	VAS leg pain		48 weeks
Secondary	ODI	Oswestry disability index	48 weeks
Secondary	complications	Nerve injury, foot drop, dura tear	48 weeks
Secondary	re-operation		48 weeks