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

Stockholm Spine Center AB80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiculopathy

Interventions

ACDFPROCEDURE

minimal invasive Posterior Cervical ForaminotomyPROCEDURE

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Neck Disability Index

Time frame: 24 months

Central Contacts

Andreas Selander, MD

CONTACT

andreas.selander@spinecenter.se

Anton Rasch, MD, PhD

CONTACT

anton.rasch@spinecenter.se

Data from ClinicalTrials.gov

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