Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Iā¦ (NCT03979443) | Clinical Trial Compass
CompletedNot Applicable
Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care
Finland104 participantsStarted 2019-06-12
Plain-language summary
FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion (ACDF) procedure.
Who can participate
Age range18 Years ā 62 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Cervical radiculopathy syndrome (CRS) unresponsive to non-operative treatment for at least six weeks or with severe progressive signs and symptoms of nerve root compression during conservative treatment of shorter duration.
ā. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8.
ā. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms
ā. Neck Disability Index score ā„30 out of 100
ā. Age between 18 to 62 years
ā. No previous cervical operations
ā. Currently employed
ā. No co-morbidities causing a need for a sick leave
Exclusion criteria
ā. MRI finding inconsistent with patient's symptoms
ā. Diagnosed osteoporosis or permanent use of oral corticosteroids
ā. ACDF operation requiring plate or cage fixation with screws
ā. Active malignancy
ā. American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients)
What they're measuring
1
Change from baseline Neck Disability Index at 6 months after operation
Timeframe: Before and up to 6 months after operation