ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02486107
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Kyungpook National University
Information provided by (Responsible Party):
Chun Kee Chung, Seoul National University Hospital

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.


Condition or disease Intervention/treatment
Spinal Curvature Procedure: surgical procedure

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
Estimated Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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



Primary Outcome Measures :
  1. change of segmental angle [ Time Frame: postoperative 1 year ]

Secondary Outcome Measures :
  1. operation time [ Time Frame: postoperative 1 year ]
  2. neck/arm pain [ Time Frame: postop 1 year ]
  3. neck disability, index [ Time Frame: postop 1 year ]
  4. cervical curvature [ Time Frame: postop 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486107


Contacts
Contact: Chun Kee Chung, Professor +82-2-2072-2352 chungc@snu.ac.kr
Contact: Chi Heon Kim, Ass prof. +82-2-2072-3398 chiheon1@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seong-Nam, Kyung-gi, Korea, Republic of
Contact: Seung-Jae Hyun, MD, PhD       neurospine@snubh.org   
Kyoung-Pook National University Hospital Recruiting
DeaKu, Kyungsangbookdo, Korea, Republic of
Contact: Kyoung-Tae Kim, MD, PhD       nskimkt7@gmail.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chi Heon Kim, MD, PhD    +82-2-2072-2358    chiheon1@snu.ac.kr   
Principal Investigator: Chun Kee Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Kyungpook National University
Investigators
Principal Investigator: Chun Kee Chung, Professor Seoul National University Hospital

Responsible Party: Chun Kee Chung, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02486107     History of Changes
Other Study ID Numbers: PECD
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Chun Kee Chung, Seoul National University Hospital:
cervical vertebra
surgery
tubular retractor
endoscope

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases