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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05140733

Enrollment

Registered

2021-12-01

Start date

2021-08-22

Completion date

2024-02-28

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Foraminal Stenosis

Keywords

Cost-effectiveness, surgery, deformity

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

Interventions

PROCEDURElumbar foraminal decompression

lumbar foraminal decompression with endoscopic instruments.

PROCEDUREFusion surgery

Fusion surgery for patients with foraminal stenosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 100 Years

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
Cost-effectiveness	preoperation	cost to increased one quality adjusted life year (QALY) after surgical treatment

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026