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Open Access 01-04-2017 | Original Article

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion—a prospective, single-blinded, randomized, controlled multicenter study

Authors: Jarle Sundseth, Oddrun Anita Fredriksli, Frode Kolstad, Lars Gunnar Johnsen, Are Hugo Pripp, Hege Andresen, Erling Myrseth, Kay Müller, Øystein P. Nygaard, John-Anker Zwart, On behalf of the NORCAT study group

Published in: European Spine Journal | Issue 4/2017

Abstract

Purpose

Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion.

Methods

This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level.

Results

There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty.

Conclusion

The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty.

Trial registration

http://www.clinicaltrials.gov NCT 00735176.19.

Available only for authorised users

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Title: The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion—a prospective, single-blinded, randomized, controlled multicenter study
Authors: Jarle Sundseth
Oddrun Anita Fredriksli
Frode Kolstad
Lars Gunnar Johnsen
Are Hugo Pripp
Hege Andresen
Erling Myrseth
Kay Müller
Øystein P. Nygaard
John-Anker Zwart
On behalf of the NORCAT study group
Publication date: 01-04-2017
Publisher: Springer Berlin Heidelberg
Published in: European Spine Journal / Issue 4/2017
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-016-4922-5

2024 ASCO Annual Meeting

Springer Medicine

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion—a prospective, single-blinded, randomized, controlled multicenter study

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

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