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

April 16, 2024 updated by: Chun Kee Chung, Seoul National University Hospital

Prospective Cohort Study of Outcome After Minimally Invasive Posterior Surgery (Posterior Percutaneous Endoscopic Foraminotomy or Tubular Retractor Assisted Micro-foraminotomy) for Single Level Cervical Foraminal Stenosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Bundang Hospital
    • Province
      • Seoul, 03080, Province, Korea, Republic of, 03080
        • Kyoung-Pook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of segmental angle
Time Frame: postoperative 1 year
postoperative 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
operation time
Time Frame: postoperative 1 year
postoperative 1 year
neck/arm pain
Time Frame: postop 1 year
postop 1 year
neck disability, index
Time Frame: postop 1 year
postop 1 year
cervical curvature
Time Frame: postop 1 year
postop 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital
Kyungpook National University Hospital

Investigators

  • Principal Investigator: Chun Kee Chung, Professor, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PECD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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