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

Spinal Curvature Clinical Trial

— PECD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486107
• Other study ID #: PECD
• Status: Completed
• Start date: May 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Curvature
• Spinal Curvatures

Intervention

Procedure:
• surgical procedure

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Kyoung-Pook National University Hospital	Seoul, 03080	Province

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Kyungpook National University Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of segmental angle		postoperative 1 year
Secondary	operation time		postoperative 1 year
Secondary	neck/arm pain		postop 1 year
Secondary	neck disability, index		postop 1 year
Secondary	cervical curvature		postop 1 year