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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Foraminal Stenosis
• Intervention / Treatment: Procedure: Fusion surgery; Procedure: lumbar foraminal decompression

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

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

26 patients in each foraminotomy and fusion group.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fusion; 1 or 2 levels fusion surgery	Procedure: Fusion surgery; Fusion surgery for patients with foraminal stenosis
Foraminotomy; 1 or 2 levels lumbar foraminotomy	Procedure: lumbar foraminal decompression; lumbar foraminal decompression with endoscopic instruments.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: surgery; Cost-effectiveness; deformity
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: Foraminotomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I am willing to share all data after publication.
• IPD Sharing Time Frame: after publication of study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No