Status:
COMPLETED
The Norwegian Cervical Arthroplasty Trial
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
Rikshospitalet University Hospital
Haukeland University Hospital
Conditions:
Radiculopathy, Cervical
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief 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, w...
Detailed Description
Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last decade cervical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00735176
Start Date
September 1 2008
End Date
August 1 2017
Last Update
January 11 2019
Active Locations (1)
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1
St. Olavs Hospital
Trondheim, Norway, 7004