Prospective Cohort Study of Outcome After Minimally Invasive Posterior Cervical Spine Surgery
PECD
1 other identifier
observational
156
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 18, 2024
April 1, 2024
4.6 years
May 20, 2015
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of segmental angle
postoperative 1 year
Secondary Outcomes (4)
operation time
postoperative 1 year
neck/arm pain
postop 1 year
neck disability, index
postop 1 year
cervical curvature
postop 1 year
Study Arms (3)
PECD
percutaneous endoscopic cervical foraminotomy
MTPF
microscopic tubular retractor assisted foraminotomy
ACDF
anterior cervical discectomy and fusion
Interventions
Eligibility Criteria
Alpha = 0.05, Beta = 0.2, q1 = 0.5, effect size = 0.6 drop rate 12% 52 patients in each group
You may qualify if:
- cervical radicular pain
- no cervical myelopathy
You may not qualify if:
- motor weakness less than MMT Gr III
- cervical myelopathy
- OPLL and myelopathy
- previous cervical spine surgery
- combined fracture or spinal tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kyoung-Pook National University Hospital
Seoul, Province, 03080, South Korea
Seoul National University Bundang Hospital
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun Kee Chung, Professor
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 20, 2015
First Posted
July 1, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
April 18, 2024
Record last verified: 2024-04