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Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.

Primary Purpose

Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACDF
minimal invasive Posterior Cervical Foraminotomy
Sponsored by
Stockholm Spine Center AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring cervical foraminal stenosis minimal invasive foraminotomy

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.

Exclusion Criteria:

  • Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ACDF

    miPCF

    Arm Description

    Anterior Cervical Discectomy and Fusion

    minimal invasive Posterior Cervical Foraminotomy

    Outcomes

    Primary Outcome Measures

    Neck Disability Index

    Secondary Outcome Measures

    Full Information

    First Posted
    January 26, 2015
    Last Updated
    January 26, 2015
    Sponsor
    Stockholm Spine Center AB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02350621
    Brief Title
    Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.
    Official Title
    Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stockholm Spine Center AB

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy. 80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiculopathy
    Keywords
    cervical foraminal stenosis minimal invasive foraminotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ACDF
    Arm Type
    Active Comparator
    Arm Description
    Anterior Cervical Discectomy and Fusion
    Arm Title
    miPCF
    Arm Type
    Active Comparator
    Arm Description
    minimal invasive Posterior Cervical Foraminotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    ACDF
    Intervention Type
    Procedure
    Intervention Name(s)
    minimal invasive Posterior Cervical Foraminotomy
    Primary Outcome Measure Information:
    Title
    Neck Disability Index
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months. Exclusion Criteria: Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andreas Selander, MD
    Email
    andreas.selander@spinecenter.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anton Rasch, MD, PhD
    Email
    anton.rasch@spinecenter.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tycho Tullberg, MD, PhD
    Organizational Affiliation
    Stockholm Spine Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.

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