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Completed

NCT Number: NCT02486107

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

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.

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Key information

Conditions

Spinal Curvature Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyoung-Pook National University Hospital, Seoul, Province, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Procedure

Procedure

Primary outcomes

  1. change of segmental angle

    Time frame: postoperative 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Kyungpook National University Hospital
  • Seoul National University Bundang Hospital

Registry information

Official study 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

Acronym: PECD

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2015
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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