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The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervi...

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervi...

https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_1891870314

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

About this item

Full 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

Publisher

Berlin/Heidelberg: Springer Berlin Heidelberg

Journal title

European spine journal, 2017-04, Vol.26 (4), p.1225-1235

Language

English

Formats

Publication information

Publisher

Berlin/Heidelberg: Springer Berlin Heidelberg

More information

Scope and Contents

Contents

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....

Alternative Titles

Full 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

Identifiers

Primary Identifiers

Record Identifier

TN_cdi_proquest_miscellaneous_1891870314

Permalink

https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_1891870314

Other Identifiers

ISSN

0940-6719

E-ISSN

1432-0932

DOI

10.1007/s00586-016-4922-5

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