The Product Under Application Includes Both Cervical Intervertebral Fusion Cage And Lumbar Intervertebral Fusion Cage. If Clinical Trials Are Carried Can Just One Of These Fusion Cages Be Selected For The Clinical Trial Or Must Both Cervical And Thoracolumbar Fusion Cages Be Used In The Clinical Trial?


In the case that the product under application includes both cervical intervertebral fusion cage and lumbar intervertebral fusion cage, if clinical trials are carried out, under the homogenous condition on cervical and thoracolumbar cases enrolled, that is, until the end of the follow-up time, the spinal internal fixation system in the diseased segment treated has not been removed, in order to ensure the comparability between the investigational group and the control group, the cervical and thoracolumbar indications can be combined for clinical trials. It is recommended that each group include cervical or thoracolumbar spine cases, which are not less than one third of the total number of cases in this group.