Outcomes of Patients With Foraminal Stenosis

Lumbar Foraminal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140733
• Other study ID #: Foraminotomy
• Status: Completed
• Start date: August 22, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Foraminal Stenosis

Intervention

Procedure:
• lumbar foraminal decompression
lumbar foraminal decompression with endoscopic instruments.
• Fusion surgery
Fusion surgery for patients with foraminal stenosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-effectiveness	cost to increased one quality adjusted life year (QALY) after surgical treatment	preoperation
Primary	Cost-effectiveness	cost to increased one quality adjusted life year (QALY) after surgical treatment	postoperative 6 months
Primary	Cost-effectiveness	cost to increased one quality adjusted life year (QALY) after surgical treatment	postoperative 1 year
Primary	Cost-effectiveness	cost to increased one quality adjusted life year (QALY) after surgical treatment	postoperative 2 years
Secondary	Oswestry disability index (ODI)	ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.	preoperation
Secondary	Oswestry disability index (ODI)	ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.	postoperative 6 months
Secondary	Oswestry disability index (ODI)	ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.	postoperative 1 year
Secondary	Oswestry disability index (ODI)	ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.	postoperative 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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.