1.
Chinese Journal of Medical Instrumentation
;
(6): 279-281, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-265643
ABSTRACT
Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome.