Outcomes of Patients With Foraminal Stenosis

NCT05140733 | Completed

• 1 other identifier: Foraminotomy
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Foraminal Stenosis

Keywords

Cost-effectiveness; surgery; deformity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Oswestry disability index (ODI)

  preoperation

• Oswestry disability index (ODI)

  postoperative 6 months

• Oswestry disability index (ODI)

  postoperative 1 year

• Oswestry disability index (ODI)

  postoperative 2 years

• Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)

  preoperation

Study Arms (2)

Fusion

1 or 2 levels fusion surgery

Procedure: Fusion surgery

Foraminotomy

1 or 2 levels lumbar foraminotomy

Procedure: lumbar foraminal decompression

Interventions

lumbar foraminal decompression PROCEDURE

lumbar foraminal decompression with endoscopic instruments.

Foraminotomy

Fusion surgery PROCEDURE

Fusion surgery for patients with foraminal stenosis

Fusion

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

26 patients in each foraminotomy and fusion group.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: December 1, 2021
• Study Start: August 22, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication of study results.

Locations

KR (1)