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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05140733
Study type Observational
Source Seoul National University Hospital
Contact
Status Completed
Phase
Start date August 22, 2021
Completion date February 28, 2024

See also
  Status Clinical Trial Phase
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Completed NCT02985138 - Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS N/A