NCT00735176

The Norwegian Cervical Arthroplasty Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Radiculopathy, Cervical

Interventions

Type	Name	Description
PROCEDURE	Cervical arthroplasty	Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
PROCEDURE	Anterior cervical discectomy and fusion (ACDF)	Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

Timeline

• Start date: 2008-09-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2008-08-14
• Last updated: 2019-01-11

Locations

1 site across 1 country: Norway