Outcomes of Patients With Foraminal Stenosis

Last updated: March 13, 2024
Sponsor: Seoul National University Hospital
Overall Status: Completed

Phase

N/A

Condition

Spondylolisthesis

Treatment

lumbar foraminal decompression

Fusion surgery

Clinical Study ID

NCT05140733
Foraminotomy
  • Ages 40-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: lumbar foraminal decompression
Phase:
Study Start date:
August 22, 2021
Estimated Completion Date:
February 28, 2024

Study 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

Connect with a study center

  • Seoul National University Hospital

    Seoul, Korea 03080
    Korea, Republic of

    Site Not Available

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