Outcomes of Patients With Foraminal Stenosis

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Lumbar Foraminal Stenosis

Intervention / Treatment
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* Procedure: lumbar foraminal decompression
* Procedure: Fusion surgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fusion<br>1 or 2 levels fusion surgery | Procedure: Fusion surgery<br>* Fusion surgery for patients with foraminal stenosis<br>|
| Foraminotomy<br>1 or 2 levels lumbar foraminotomy | Procedure: lumbar foraminal decompression<br>* lumbar foraminal decompression with endoscopic instruments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | cost to increased one quality adjusted life year (QALY) after surgical treatment | preoperation | 
| Cost-effectiveness | cost to increased one quality adjusted life year (QALY) after surgical treatment | postoperative 6 months | 
| Cost-effectiveness | cost to increased one quality adjusted life year (QALY) after surgical treatment | postoperative 1 year | 
| Cost-effectiveness | cost to increased one quality adjusted life year (QALY) after surgical treatment | postoperative 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index (ODI) | ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years. | preoperation | 
| Oswestry disability index (ODI) | ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years. | postoperative 6 months | 
| Oswestry disability index (ODI) | ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years. | postoperative 1 year | 
| Oswestry disability index (ODI) | ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years. | postoperative 2 years | 
| Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L) | 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. | preoperation | 
| Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L) | 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. | postoperative 6 months | 
| Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L) | 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. | postoperative 1 year | 
| Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L) | 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. | postoperative 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Cost-effectiveness, deformity