The Norwegian Cervical Arthroplasty Trial (NORCAT)

Norwegian University of Science and Technology

Status: Completed

Conditions: Radiculopathy, Cervical

Treatments: Procedure: Cervical arthroplasty; Procedure: Anterior cervical discectomy and fusion (ACDF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00735176

4.2008.211 (REK)

18809/2/AMS (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 136 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Artificial Cervical Disc

Experimental group

Description:

Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc

Treatment:

Procedure: Cervical arthroplasty

ACDF

Active Comparator group

Description:

Anterior cervical discectomy and fusion (ACDF)

Treatment:

Procedure: Anterior cervical discectomy and fusion (ACDF)