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No justification for cervical disk prostheses in clinical practice: a meta-analysis of randomized controlled trials.

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Publication year
2010Source
Neurosurgery, 66, 6, (2010), pp. 1153-60; discussion 1160ISSN
Annotation
01 juni 2010
Publication type
Article / Letter to editor

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Organization
Neurosurgery
Health Evidence
Former Organization
Epidemiology, Biostatistics & HTA
Journal title
Neurosurgery
Volume
vol. 66
Issue
iss. 6
Page start
p. 1153
Page end
p. 60; discussion 1160
Subject
DCN 1: Perception and Action; NCEBP 1: Molecular epidemiology; NCEBP 2: Evaluation of complex medical interventions; NCEBP 4: Quality of hospital and integrated care; ONCOL 5: Aetiology, screening and detectionAbstract
OBJECTIVE: A meta-analysis was performed to evaluate whether a beneficial clinical effect of cervical disk prostheses over conventional cervical diskectomy with fusion exists. METHODS: A literature search was completed ending February 4, 2009, that included the abstract books of recent major spine congresses. All studies reported the results of single-level cervical disease without myelopathy. The Visual Analog Score (VAS) of the arm, VAS of the neck, Neck Disability Index, Physical Composite Scores of the Short Form 36, and Mental Composite Score of the Short Form 36, as well as adverse events, were evaluated. RESULTS: Nine records were found, totaling 1533 patients. Of these, 1165 were evaluable at the last follow-up at 12 or 24 months. As an effect measure, a pooled odds ratio (OR) was calculated at 12 and 24 months. At 12 months, the VAS arm reached statistical significance (OR = 0.698; 95% confidence interval [CI], 0.571-0.853), as did the VAS neck (OR = 0.690; 95% CI, 0.562-0.847), and the Physical Composite Scores (OR = 1.362; 95% CI, 1.103-1.682) and the Mental Composite Score (OR = 1.270; 95% CI, 1.029-1.569) of the Short Form 36, favoring arthroplasty. The Neck Disability Index at 24 months also reached statistical difference (OR = 0.794; 95% CI, 0.641-0.984). All other measurements did not reveal any statistical difference. The number of complications, including secondary surgeries for adjacent segment disease, did not differ. CONCLUSION: A clinical benefit for the cervical disk prosthesis is not proven. Because none of the studies were blinded, bias of the patient or researcher is a probable explanation for the differences found. Therefore, these costly devices should not be used in daily clinical practice.
This item appears in the following Collection(s)
- Academic publications [244578]
- Electronic publications [132441]
- Faculty of Medical Sciences [92890]
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