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

Completed

• Conditions: Spinal Curvature

• Registration Number: NCT02486107
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Primary Completion: 2019-12
• Study Completion: 2020-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of segmental angle	postoperative 1 year

Secondary Outcome Measures

Name	Time	Method
operation time	postoperative 1 year
neck/arm pain	postop 1 year
neck disability, index	postop 1 year
cervical curvature	postop 1 year

Trial Locations

Locations (3)

Kyoung-Pook National University Hospital; 🇰🇷 Seoul, 03080, Province, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of