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

Stockholm Spine Center AB

Status: Unknown

Conditions: Radiculopathy

Treatments: Procedure: minimal invasive Posterior Cervical Foraminotomy; Procedure: ACDF

Study type: Interventional

Funder types: Other

Identifiers

NCT02350621

2014/1150-31/2

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

ACDF

Active Comparator group

Description:

Anterior Cervical Discectomy and Fusion

Treatment:

Procedure: ACDF

miPCF

Active Comparator group

Description:

minimal invasive Posterior Cervical Foraminotomy

Treatment:

Procedure: minimal invasive Posterior Cervical Foraminotomy