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

NCT ID: NCT02350621

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-02-28

Brief Summary

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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

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Conditions

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Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACDF

Anterior Cervical Discectomy and Fusion

Group Type ACTIVE_COMPARATOR

ACDF

Intervention Type PROCEDURE

miPCF

minimal invasive Posterior Cervical Foraminotomy

Group Type ACTIVE_COMPARATOR

minimal invasive Posterior Cervical Foraminotomy

Intervention Type PROCEDURE

Interventions

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ACDF

Intervention Type PROCEDURE

minimal invasive Posterior Cervical Foraminotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm Spine Center AB

OTHER

Sponsor Role lead

Responsible Party

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Andreas Selander

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tycho Tullberg, MD, PhD

Role: STUDY_CHAIR

Stockholm Spine Center

Central Contacts

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Andreas Selander, MD

Role: CONTACT

Anton Rasch, MD, PhD

Role: CONTACT

Other Identifiers

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2014/1150-31/2

Identifier Type: -

Identifier Source: org_study_id

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