Prospective Cohort Study of Outcome After Minimally Invas... | NCT02486107

Studies
Prospective Cohort Study of Outcome After Minimally Invasive Posterior Cervical Spine Surgery

NCT02486107

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 18, 2024Actual

Enrollment

156Actual

Phase

Not provided

Conditions

Spinal Curvature

Interventions

surgical procedure

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

Apr 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

May 2015Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2020Actual

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

Jun 26, 2015

First Posted Date

Jul 1, 2015Estimated

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

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Kee Chung, professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Seoul National University Bundang Hospital	OTHER
Kyungpook National University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no comparative study.

The primary object of the study is to compare radiological outcome (segment angle) after MTPF or P-PECD.

Detailed Description

P-PECDs are performed in Seoul National University Hospital MTPFs are performed in Kyoung-Pook National University Hospital and ACDF are performed in Seoul National University Bundang Hospital.

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

156Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
PECD	percutaneous endoscopic cervical foraminotomy	Procedure: surgical procedure
MTPF	microscopic tubular retractor assisted foraminotomy	Procedure: surgical procedure
ACDF	anterior cervical discectomy and fusion	Procedure: surgical procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical procedure	Procedure		ACDF MTPF PECD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of segmental angle		postoperative 1 year

Secondary Outcomes

Measure	Description	Time Frame
operation time		postoperative 1 year
neck/arm pain		postop 1 year
neck disability, index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cervical radicular pain
no cervical myelopathy

Exclusion Criteria:

motor weakness less than MMT Gr III
cervical myelopathy
OPLL and myelopathy
previous cervical spine surgery
combined fracture or spinal tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Alpha = 0.05, Beta = 0.2, q1 = 0.5, effect size = 0.6 drop rate 12% 52 patients in each group

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chun Kee Chung, Professor	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyoung-Pook National University Hospital		Seoul	Province	03080	South Korea
Seoul National University Bundang Hospital

Condition Browse Module

MeSH Terms

ID	Term
D013121	Spinal Curvatures

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided