Clinical trial NCT05140733: Outcomes of Patients With Foraminal Stenosis
Official title: Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Foraminal Stenosis
Keywords: Cost-effectiveness
surgery
deformity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 26 patients in each foraminotomy and fusion group.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Cost-effectiveness
timeFrame: preoperation
measure: Cost-effectiveness
timeFrame: postoperative 6 months
measure: Cost-effectiveness
timeFrame: postoperative 1 year
measure: Cost-effectiveness
timeFrame: postoperative 2 years
Secondary outcomes:
measure: Oswestry disability index (ODI)
timeFrame: preoperation
measure: Oswestry disability index (ODI)
timeFrame: postoperative 6 months
measure: Oswestry disability index (ODI)
timeFrame: postoperative 1 year
measure: Oswestry disability index (ODI)
timeFrame: postoperative 2 years
measure: Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
timeFrame: preoperation
measure: Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
timeFrame: postoperative 6 months
measure: Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
timeFrame: postoperative 1 year
measure: Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
timeFrame: postoperative 2 years.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
References: