NCT02350621UnknownNot Applicable
Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
Stockholm Spine Center AB0 sites80 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Neck Disability Index
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ACDF
Active Comparator
Anterior Cervical Discectomy and Fusion
Intervention: ACDF (Procedure)
miPCF
Active Comparator
minimal invasive Posterior Cervical Foraminotomy
Intervention: minimal invasive Posterior Cervical Foraminotomy (Procedure)
Outcomes
Primary Outcomes
Neck Disability Index
Time Frame: 24 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Andreas Selander
MD
Stockholm Spine Center AB
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