Why is this trial needed?
Cervical radiculopathy syndrome (CRS) or radiating arm pain caused by cervical nerve root irritation is a common complaint in otherwise healthy working-aged population with an annual incidence of approximately 0.8 per 1000 inhabitants. Conservative treatment is a viable alternative for the majority of CRS patients, as their symptoms are periodic and improve with time. However, a considerable proportion of CRS patients experience persisting symptoms severe enough to justify neurosurgical intervention.
To date, no randomised trial has compared outpatient to inpatient care in patients who have undergone ACDF, particularly with a special emphasis on the patients’ immediate perceptions of the care given and their self-perceived ability to return to normal daily activities and work. We will conduct a pragmatic, randomized, non-inferiority trial comparing the traditional hospital surveillance (inpatient) to outpatient care (same day discharge, within 6-8 hours after procedure) for patients undergoing ACDF procedure.
What is the primary objective of the FACADE trial?
We hypothesize that with the current technique of performing ACDF, the outcome of patients in the outpatient care group is not worse than in the conventional postoperative strategy (inpatient care). We further hypothesize that patients treated on an outpatient basis would perceive themselves to be less disabled, subsequently encouraging them to return more quickly to their normal daily activities and work.
Where are we now?
The trial has started in the beginning of June. Manuscript for protocol has been sent to be evaluated.
