NCT05140733

Outcomes of Patients With Foraminal Stenosis

Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: —

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.

Detailed 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

Conditions

• Lumbar Foraminal Stenosis

Interventions

Type	Name	Description
PROCEDURE	lumbar foraminal decompression	lumbar foraminal decompression with endoscopic instruments.
PROCEDURE	Fusion surgery	Fusion surgery for patients with foraminal stenosis

Timeline

• Start date: 2021-08-22
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2021-12-01
• Last updated: 2024-03-15

Locations

1 site across 1 country: South Korea