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Spine J. 2015 Feb 27. pii: S1529-9430(15)00205-3. doi: 10.1016/j.spinee.2015.02.039. [Epub ahead of print]
The Discover Artificial Disc Replacement versus Fusion in Cervical Radiculopathy - A Randomized Controlled Outcome Trial with Two Years follow-up.
Skeppholm M, Lindgren L, Henriques T, Vavruch L, Löfgren H, Olerud C.
Author information
Abstract
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 U.S. 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 two years.
STUDY DESIGN/SETTING:
Randomized controlled multicenter trial, including three spine centers in Sweden.
PATIENT SAMPLE:
Patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included.
OUTCOME MEASURES:
Self-assessment with NDI as primary outcome variable and EQ-5D and VAS as secondary outcome variables.
METHODS:
Patients 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 patient and caregivers until time for implantation. Adverse events, complications, and revision surgery was registered as well as loss of follow-up.
RESULTS:
Data was available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI 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 NDI values of 39.1 and 40.1 respectively. Nor in secondary outcome measures (EQ-5D and VAS) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups.
CONCLUSION:
Artificial disc replacement did not result in better outcome compared to fusion measured with Neck Disability Index two years after surgery.
The Discover Artificial Disc Replacement versus Fusion in Cervical Radiculopathy - A Randomized Controlled Outcome Trial with Two Years follow-up.
Skeppholm M, Lindgren L, Henriques T, Vavruch L, Löfgren H, Olerud C.
Author information
Abstract
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 U.S. 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 two years.
STUDY DESIGN/SETTING:
Randomized controlled multicenter trial, including three spine centers in Sweden.
PATIENT SAMPLE:
Patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included.
OUTCOME MEASURES:
Self-assessment with NDI as primary outcome variable and EQ-5D and VAS as secondary outcome variables.
METHODS:
Patients 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 patient and caregivers until time for implantation. Adverse events, complications, and revision surgery was registered as well as loss of follow-up.
RESULTS:
Data was available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI 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 NDI values of 39.1 and 40.1 respectively. Nor in secondary outcome measures (EQ-5D and VAS) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups.
CONCLUSION:
Artificial disc replacement did not result in better outcome compared to fusion measured with Neck Disability Index two years after surgery.
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