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Chapter 10
MRI evaluation (Chapter 8) showed good agreement on the clinically relevant level of lumbar spinal stenosis between experienced readers. However, MRI assessment of grading of compression did not correlate with baseline complaints of INC, nor with outcome after one year. However, both absence of epidural fat and presence of tortuous caudal nerves on MR images in patients with LSS were relatively good predictors for satisfactory recovery after surgery. MRI should therefore only be used to appoint the pathological level in case surgical decompression is considered.
Conclusions
The clinical introduction of novel medical devices, such as the introduction of IPDs, often occurs without high quality evidence and with little regulation compared to pharmaceutical interventions. As a consequence the safety, efficacy and long-term effects for patients are insufficiently guaranteed. IPDs heave been used for over thirty years, while good clinical data are becoming available only now. Treatment with IPD did not show any societal benefit though it is responsible for higher health care costs. The controversies surrounding the implementation of IPDs underscore the need to reconsider how innovation in medical devices and surgical techniques should adhere to sound ethical standards without inhibiting surgical research and development (Chapter 9). Ethical lessons should be learned from the history in the past thirty years of the introduction of various devices. There is no such thing as the ‘no lose’ philosophy: patients are harmed by new developments. We suggest that this might be prevented by demanding prospective studies upon device introduction, and by developing (European) registries in order to monitor and evaluate new medical devices.
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