Spine
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A clinicobiomechanical study. ⋯ N/A.
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Retrospective radiographical review by 5 independent observers. ⋯ 2.
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⋯ 3.
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Retrospective cohort study. ⋯ 3.
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The clinical introduction of novel medical devices often occurs without evidence of good methodological quality and with relatively little oversight and regulation. As a consequence, the safety, efficacy, and long-term effects of devices are frequently insufficiently known upon device approval. ⋯ Two measures for improvement are most feasible in the short term: demanding prospective studies before device introduction and developing registries to monitor and evaluate new medical devices. Level of evidence: 5.