The Norwegian Cervical Arthroplasty Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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 arthroplasty has emerged as a new alternative operative method. Arthroplasty is claimed to preserve the natural motion of the spine, thereby preventing adjacent level disc disease and providing better clinical results. However, this hypothesis has not yet been adequately proven. In our study, we will prove if there is any real difference in terms of clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs of the two methods, including cost-utility analyses. Moreover, we will study the development of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc height by use of Distortion Compensated Roentgen Analysis (DCRA).

Official Title
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Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.

Conditions
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Radiculopathy, Cervical

Intervention / Treatment
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* Procedure: Cervical arthroplasty
* Procedure: Anterior cervical discectomy and fusion (ACDF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Cervical Disc<br>Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc | Procedure: Cervical arthroplasty<br>* Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc<br>* Other names: Discover™ Artificial Cervical Disc;|
| Active Comparator: ACDF<br>Anterior cervical discectomy and fusion (ACDF) | Procedure: Anterior cervical discectomy and fusion (ACDF)<br>* Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.<br>* Other names: Cage is made of polyetheretherketone (PEEK);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Neck Disability Index (NDI) |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity |  | Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years | 
| Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses. |  | Postoperatively: 3 months, 6 months, 1 year, 2 years | 
| Adjacent level disc disease, measured by use of MRI scans. |  | Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years | 
| Preservation of cervical translational and rotational segmental motion, disc height and dorsoventral displacement, by use of functional X-rays with Distortion Compensated Roentgen Analysis (DCRA) |  | Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiculopathy, cervical, Nerve Root Compression, Disc, intervertebral, Intervertebral Disk Displacement, Spondylosis, Spinal Osteophytosis, Arthroplasty, replacement, Diskectomy, Spinal Fusion