Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy

NCT04177849 | Unknown DMC

• 1 other identifier: 2019-00003
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Pain; Nerve root dysfunction; Anterior Cervical Decompression and Fusion; Posterior Foraminotomy

Outcome Measures

Primary Outcomes (1)

• Neck Disability index, NDI.

  Primary variable is NDI change at two year compared to baseline. NDI is a self-administered questionnaire with 10 items measuring disability in patients with neck pain. The questions cover daily activities, such as the ability to dress, lift heavy objects, read, work, drive a car, sleep and perform leisure time activities, as well as the amount of pain, headache and concentration abilities. Each item is scored from 0 to 5. MCID for NDI is 7,5-8,5 or 17,3%. NDI change will also be measured at different time intervals to highlight the change over time.

  4-6 weeks, 3 months, 1 year, 2 year, 5 year

Secondary Outcomes (2)

• EQ-5D

  4-6 weeks, 3 months, 1 year, 2 year, 5 year

• NRS neck, NRS arm

  4-6 weeks, 3 months, 1 year, 2 year, 5 year

Study Arms (2)

Anterior Cervical Decompression and Fusion (ACDF)

ACTIVE COMPARATOR

Patients entered into this arm are treated via an anterior approach with disk excision, root canal decompression and fusion of the affected segment with a cage and plate.

Procedure: ACDF

Posterior Foraminotomy (PF)

EXPERIMENTAL

Patients entered into this arm are treated via a posterior approach through intermuscular planes. The root canal is decompressed by burring the medial third of the facet joint. No fusion is performed.

Procedure: PF

Interventions

ACDF PROCEDURE

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.

Anterior Cervical Decompression and Fusion (ACDF)

PF PROCEDURE

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.

Posterior Foraminotomy (PF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of radiating arm pain with duration of at least six weeks
• Neck disability index (NDI) over 30 points (60%);
• Correlating findings on MRI on one or two cervical levels
• Eligible for both treatments
• Ability to understand and read Swedish.

You may not qualify if:

• Previous cervical spine surgery
• More then two cervical levels requiring treatment
• Severe facet joint osteoarthritis
• Symptoms or marked radiologic signs of myelopathy
• Drug abuse
• Dementia or expected low compliance
• Cervical malformation
• Marked instability, 3.5-mm translation or \>11 degrees more motion compared to adjacent segments
• History of severe cervical trauma
• Generalized pain syndrome or WAD
• Pregnancy
• Rheumatoid arthritis
• Ankylosing spondylitis
• Malignancy
• Active infection or another severe systemic disease

Sponsors & Collaborators

• Region Örebro County: lead
• Uppsala University Hospital: collaborator
• Rygglkirurgiskt Centrum Stockholm AB: collaborator
• Norrlands University Hospital: collaborator

Study Sites (4)

Universistessjukhuset Örebro

Örebro, 701 85, Sweden

RECRUITING

Ryggkirurgiskt Centrum Stockholm

Stockholm, 114 33, Sweden

RECRUITING

Norrlands Universitetssjukhus

Umeå, 90737, Sweden

NOT YET RECRUITING

Akademiska Sjukhuset Uppsala

Uppsala, 75185, Sweden

RECRUITING

Related Publications (1)

• Holy M, MacDowall A, Sigmundsson FG, Olerud C. Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):607. doi: 10.1186/s13063-021-05492-2.

  PMID: 34496941 DERIVED

MeSH Terms

Conditions

Radiculopathy; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Wretenberg, Prof. MD. PhD

  Region Örebro County

  STUDY CHAIR

• Claes Olerud, Prof. MD. PhD

  Uppsala University

  STUDY DIRECTOR

Central Study Contacts

Marek Holy, MD

CONTACT

+46 0196025323; marek.holy@regionorebrolan.se

Claes Olerud, Prof. MD. PhD

CONTACT

+46 018 611 72 24; claes.olerud@surgsciuu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Spine Unit

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: January 20, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)