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Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584774
Enrollment
36
Registered
2022-10-18
Start date
2022-11-30
Completion date
2023-12-30
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation

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.

Interventions

PROCEDUREPELDAN

percutaneous endoscopic lumbar dissectomy and annuloplasty and nucleoplasty

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
VAS back pain48 weeks
VAS leg pain48 weeks

Secondary

MeasureTime frameDescription
ODI48 weeksOswestry disability index
complications48 weeksNerve injury, foot drop, dura tear
re-operation48 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026