ClinicalTrials.Veeva

Menu

Outcomes of Patients With Foraminal Stenosis

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Lumbar Foraminal Stenosis

Treatments

Procedure: Fusion surgery
Procedure: lumbar foraminal decompression

Study type

Observational

Funder types

Other

Identifiers

NCT05140733
Foraminotomy

Details and patient eligibility

About

The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.

Full description

Control: 1-2 levels fusion surgery Intervention: neural foraminotomy

Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis > 10cm)

Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.

Statistical analysis means: T-test

Enrollment

52 patients

Sex

All

Ages

40 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  • patients between 40 - 100 years.
  • No improvement despite nonsurgical treatment for more than 3 months.
  • No history of lumbar fusion surgery.
  • Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion:

  • Severe neurological deficit (motor grade less than Grade III)
  • Combined inflammatory joint disease
  • Combined neurodegenerative disease such as Parkinson's disease or dementia * Combined cancer, traumatic fracture
  • Marked spinal deformity (C7 sagittal vertical axis > 10cm)

Trial design

52 participants in 2 patient groups

Fusion
Description:
1 or 2 levels fusion surgery
Treatment:
Procedure: Fusion surgery
Foraminotomy
Description:
1 or 2 levels lumbar foraminotomy
Treatment:
Procedure: lumbar foraminal decompression

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems