Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy

Summary

This study compares anterior cervical decompression and fusion (ACDF) to posterior foraminotomy (PF) in surgical treatment for cervical radiculopathy (CR) caused by root canal compression, in a multicenter prospective randomized trial. The investigators hypothesize equal decompression of nerve root, and equal clinical outcome in both treatment groups.

Conditions

• Cervical Radiculopathy
• Cervical Root Compression

Interventions

PROCEDURE

ACDF

A 4-cm anterolateral transverse incision is made over the index level, on either the right or left side. Platysma is sectioned transversal to its fibers and the anterior aspect of the spinal column is bluntly exposed between the carotid sheath and the esophagus. The disk is excised, including the posterior longitudinal ligament. Disk fragments and/or osteophytes from the uncovertebral joint on the affected side are removed until the root is fully decompressed. Reconstruction is typically done with an interbody spacer, autologous bone graft and a stabilizing plate screwed to the adjacent vertebral bodies. A fusion cage with integrated screws may also be used according to the surgeon's preference.

PROCEDURE

PF

A 4-cm longitudinal midline incision exposes the spinous processes of the adjacent vertebrae. The facet joint covering the index foramen is exposed through intermuscular planes. The root canal is opened as the medial third of the facet joint is removed with a high-speed diamond burr. The affected nerve root is decompressed by laterally undercutting the facet joint throughout its length.

Sponsors & Collaborators

• Uppsala University Hospital

  collaborator OTHER

• Rygglkirurgiskt Centrum Stockholm AB

  collaborator OTHER

• Norrlands University Hospital

  collaborator OTHER

• Region Örebro County

  lead OTHER

Principal Investigators

• Per Wretenberg, Prof. MD. PhD · Region Örebro County

• Claes Olerud, Prof. MD. PhD · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-20

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• Sweden

Study Locations