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
About this trial
This is an interventional treatment trial for Radiculopathy focused on measuring cervical foraminal stenosis minimal invasive foraminotomy
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.
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
NCT ID
NCT02350621
First Posted
January 26, 2015
Last Updated
January 26, 2015
Sponsor
Stockholm Spine Center AB
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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