St. Olavs Hospital
Trondheim, 7004, Norway
NCT Number: NCT00735176
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.
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Notify Me25 year–60 year
All sexes
Interventional
Not applicable
Trondheim, 7004, Norway
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Other names: Discover™ Artificial Cervical Disc
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
Other names: Cage is made of polyetheretherketone (PEEK)
Time frame: up to 5 years
Time frame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
Time frame: Postoperatively: 3 months, 6 months, 1 year, 2 years
Time frame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
Time frame: Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years
Norwegian University of Science and Technology
Other
Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.
Acronym: NORCAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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