UnknownNot Applicable

Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy

Sweden110 participantsStarted 2020-01-20

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patients that are unsuitable for either intervention deemed by the consultant spine surgeon

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neck Disability index, NDI.

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

Trial details

NCT IDNCT04177849

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Marek Holy, MD

+46 0196025323 marek.holy@regionorebrolan.se

View on ClinicalTrials.gov More Cervical Radiculopathy trials