Outcomes of Patients With Foraminal Stenosis | NCT05140733

Studies
Outcomes of Patients With Foraminal Stenosis

NCT05140733

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Lumbar Foraminal Stenosis

Interventions

lumbar foraminal decompression
Fusion surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2021Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Aug 22, 2021

First Submission Date that Met QC Criteria

Nov 21, 2021

First Posted Date

Dec 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chi Heon Kim, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fusion		1 or 2 levels fusion surgery	Procedure: Fusion surgery
Foraminotomy		1 or 2 levels lumbar foraminotomy	Procedure: lumbar foraminal decompression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lumbar foraminal decompression	Procedure	lumbar foraminal decompression with endoscopic instruments.	Foraminotomy

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

26 patients in each foraminotomy and fusion group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Korea	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

I am willing to share all data after publication.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

after publication of study results.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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