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

NCT ID: NCT02486107

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Curvature

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PECD

percutaneous endoscopic cervical foraminotomy

surgical procedure

Intervention Type PROCEDURE

MTPF

microscopic tubular retractor assisted foraminotomy

surgical procedure

Intervention Type PROCEDURE

ACDF

anterior cervical discectomy and fusion

surgical procedure

Intervention Type PROCEDURE

Interventions

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surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun Kee Chung

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Kee Chung, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Kyoung-Pook National University Hospital

Seoul, Province, South Korea

Site Status

Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PECD

Identifier Type: -

Identifier Source: org_study_id

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