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NCT02350621 Clinical Trial

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

Radiculopathy Clinical Trial

Official title:
Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02350621
Other study ID # 2014/1150-31/2
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 26, 2015
Last updated January 26, 2015
Start date February 2015
Est. completion date February 2018

Study information
Verified date January 2015
Source Stockholm Spine Center AB
Contact Andreas Selander, MD
Email andreas.selander@spinecenter.se
Is FDA regulated No
Health authority Sweden: Swedish National Council on Medical Ethics
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date February 2018
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 70 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• ACDF

• minimal invasive Posterior Cervical Foraminotomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Stockholm Spine Center AB

Outcome
Type Measure Description Time frame Safety issue
Primary Neck Disability Index 24 months No
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