Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: Discharge on the day of surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms Neck Disability Index score ≥30 out of 100 Age between 18 to 62 years No previous cervical operations Currently employed No co-morbidities causing a need for a sick leave Provision of informed consent from the participant No contraindication for randomization in postoperative check (see below) Exclusion Criteria: MRI finding inconsistent with patient's symptoms Diagnosed osteoporosis or permanent use of oral corticosteroids ACDF operation requiring plate or cage fixation with screws Active malignancy American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients) Pregnancy Abundant use of alcohol, drugs or narcotics No possibility to be accompanied by an adult person over the first postoperative night after the surgery Insufficient Finnish language skills Distance to the closest hospital emergency more than 60 min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Inpatient<br>patients staying in the hospital for 1-3 nights after surgery | |
| Active Comparator: Outpatient<br>discharge on the day of the surgery, usually within 6-8 hours after procedure | Procedure: Discharge on the day of surgery<br>* Patient discharge on the day of the surgery, usually within 6-8 hours after procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Neck Disability Index at 6 months after operation | Neck disability Index scale score ranges from 0 to 100%. Score 0 indicates no disability as score 100% indicates worst possible disability. | Before and up to 6 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Numeric rating scale on arm pain at six months after operation | Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain | Before and up to 6 months after operation | 
| Change from baseline Numeric rating scale on neck pain at six months after operation | Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain | Before and up to 6 months after operation | 
| Rate of returning to previous leisure activities after operation | Before the operation, participants will be asked to name the most important daily leisure activity they are not able to perform because of the disease. At each follow-up time point (Table 2), participants will be asked to respond to the following question: Have you been able to return to your leisure activity? (yes or no) | Before and up to 6 months after operation | 
| Change from baseline Work Ability Score (WAS) at six months after operation | Numeric rating score ranges from 0 to 10, where 0 indicates that participant is completely incapable to work and 10 indicates participants work ability at its best | Before and up to 6 months after operation | 
| The duration of sick leave | the number of sickness absence days from work both before and after the operation. The number of sickness absence days will be treated as a continuous variable | Before and after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol