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

Completed

• Conditions: Spinal Curvature
• Interventions: Procedure: surgical procedure

• 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

Read More

Exclusion Criteria

• motor weakness less than MMT Gr III
• cervical myelopathy
• OPLL and myelopathy
• previous cervical spine surgery
• combined fracture or spinal tumor

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACDF	surgical procedure	anterior cervical discectomy and fusion
PECD	surgical procedure	percutaneous endoscopic cervical foraminotomy
MTPF	surgical procedure	microscopic tubular retractor assisted foraminotomy

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 Hospital; 🇰🇷 Seoul, Korea, Republic of

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