The Discover artificial disc replacement versus fusion in cervical XXXX -a randomized controlled outcome trial with 2-year follow-up.

@entity1 @entity717 @entity614
BACKGROUND CONTEXT: Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study. PURPOSE: To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years. STUDY DESIGN/SETTING: This is a randomized controlled multicenter trial, including three spine centers in Sweden. @entity1 SAMPLE: The study included @entity1 seeking care for cervical @entity614 who fulfilled inclusion criteria. In total, 153 @entity1 were included. OUTCOME MEASURES: Self-assessment with @entity717 ( @entity717 ) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables. METHODS: @entity1 were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both @entity1 and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up. RESULTS: Data were available in 137 (91%) of the included and initially treated @entity1 . Both groups improved significantly after surgery. @entity717 changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with @entity717 values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine @entity1 in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two @entity1 in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups. CONCLUSIONS: Artificial disc replacement did not result in better outcome compared to fusion measured with @entity717 2 years after surgery.
