CompletedNot Applicable

The Norwegian Cervical Arthroplasty Trial

Norway136 participantsStarted 2008-09

Plain-language summary

The study will compare cervical arthroplasty with cervical discectomy and fusion, in the treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between the two methods, when comparing primary and secondary outcome variables.

Who can participate

Age range

25 Years – 60 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: * Age 25 - 60 years * Clinical C6 or C7 root radiculopathy with corresponding radiologic findings with or without neurological symptoms * Mechanical provoked pain which aggravate with physical activity or positive Spurling test * Radiological nerve root compression on the basis of disc herniation or spondylosis * NDI =/\> 30 percent * The patient has not responded to non-operative treatment and shown no sign of improvement during the last 6 weeks Exclusion Criteria: * Significant spondylosis involving more than one level * Intramedullary changes on MRI * Ankylosis at adjacent level * Clinical suspicion of myelopathy * Chronic generalised pain syndrome * Infection * Active cancer * Rheumatoid arthritis involving the cervical spine * Previous trauma involving the cervical spine * Pregnancy * Allergy against contents in cage/artificial disc * Previous neck surgery * Psychological or somatic illness that causes the patient not to be suitable for the study * The patient does not understand Norwegian orally or in writing. * Abuse of medication/narcotics

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

change in Neck Disability Index (NDI)

Timeframe: up to 5 years

Trial details

NCT IDNCT00735176

SponsorNorwegian University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Radiculopathy, Cervical trials

Who can participate

Age range

25 Years – 60 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.