Clinical trial NCT03979443: Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care
Official title: Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): A Protocol for a Prospective Randomized Non-inferiority Trial Comparing Outpatient vs. Inpatient Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Anterior cervical decompression and fusion
cervical fusion
cervical spine
spinal surgery
outpatient care
randomized controlled trial
Protocol
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Oulu University Hospital
First posted: 2019-06-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: To determine whether early discharge (outpatient care) is noninferior to inpatient care, the investigators will randomize 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that early discharge is not significantly worse (inferior) than the current care in terms of change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, within statistical variability, by a margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to health care system. Secondary outcomes in the study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS), sickness absence days, return to previous leisure activities, and complications.

Patients who are eligible for the trial, but are not willing to undergo randomization, will be asked to be included in a simultaneous, pragmatic follow-up cohort.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8.
3. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms
4. Neck Disability Index score ≥30 out of 100
5. Age between 18 to 62 years
6. No previous cervical operations
7. Currently employed
8. No co-morbidities causing a need for a sick leave
9. Provision of informed consent from the participant
10. No contraindication for randomization in postoperative check (see below)

Exclusion Criteria:

1. MRI finding inconsistent with patient's symptoms
2. Diagnosed osteoporosis or permanent use of oral corticosteroids
3. ACDF operation requiring plate or cage fixation with screws
4. Active malignancy
5. American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients)
6. Pregnancy
7. Abundant use of alcohol, drugs or narcotics
8. No possibility to be accompanied by an adult person over the first postoperative night after the surgery
9. Insufficient Finnish language skills
10. Distance to the closest hospital emergency more than 60 min

Primary outcomes:
measure: Change from baseline Neck Disability Index at 6 months after operation
timeFrame: Before and up to 6 months after operation
Secondary outcomes:
measure: Change from baseline Numeric rating scale on arm pain at six months after operation
timeFrame: Before and up to 6 months after operation
measure: Change from baseline Numeric rating scale on neck pain at six months after operation
timeFrame: Before and up to 6 months after operation
measure: Rate of returning to previous leisure activities after operation
timeFrame: Before and up to 6 months after operation
measure: Change from baseline Work Ability Score (WAS) at six months after operation
timeFrame: Before and up to 6 months after operation
measure: The duration of sick leave
timeFrame: Before and after operation
Other outcomes:
measure: Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation
timeFrame: Before and at 6 months after operation
measure: Patient satisfaction to treatment
timeFrame: at six months after operation
measure: Operative success
timeFrame: at one week, one month, three months and six months after operation
measure: Rate of complications and adverse effects
timeFrame: From operation up to six months postoperatively
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Senior neurosurgeon at Helsinki Univ. Hospital
name: Kimmo Lonnrot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lonnrot K, Taimela S, Toivonen P, Aronen P, Koski-Palken A, Frantzen J, Leinonen V, Silvasti-Lundell M, Forster J, Jarvinen T; FACADE investigators. Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care. BMJ Open. 2019 Nov 26;9(11):e032575. doi: 10.1136/bmjopen-2019-032575.