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

Not Applicable

• Conditions: Radiculopathy
• Interventions: Procedure: minimal invasive Posterior Cervical Foraminotomy; Procedure: ACDF

• Registration Number: NCT02350621
• Lead Sponsor: Stockholm Spine Center AB

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Study Start: 2015-02
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
miPCF	minimal invasive Posterior Cervical Foraminotomy	minimal invasive Posterior Cervical Foraminotomy
ACDF	ACDF	Anterior Cervical Discectomy and Fusion

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	24 months