Outcomes of Patients With Foraminal Stenosis
- Conditions
- Lumbar Foraminal Stenosis
- Interventions
- Procedure: Fusion surgeryProcedure: lumbar foraminal decompression
- Registration Number
- NCT05140733
- Lead Sponsor
- Seoul National University Hospital
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fusion Fusion surgery 1 or 2 levels fusion surgery Foraminotomy lumbar foraminal decompression 1 or 2 levels lumbar foraminotomy
- Primary Outcome Measures
Name Time Method Cost-effectiveness postoperative 2 years cost to increased one quality adjusted life year (QALY) after surgical treatment
- Secondary Outcome Measures
Name Time Method Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L) postoperative 2 years. NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Numeric rating scale (NRS)
: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.Oswestry disability index (ODI) postoperative 2 years ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Korea, Republic of