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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03979443

Collaborator

Turku University Hospital (Other), Oulu University Hospital (Other)

104

Enrollment

Location

Arms

28.6

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Radiculopathy	Procedure: Discharge on the day of surgery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 12, 2019

Actual Primary Completion Date :

Oct 30, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Inpatient

patients staying in the hospital for 1-3 nights after surgery

Active Comparator: Outpatient

discharge on the day of the surgery, usually within 6-8 hours after procedure

Procedure: Discharge on the day of surgery

Patient discharge on the day of the surgery, usually within 6-8 hours after procedure

Outcome Measures

Primary Outcome Measures

Change from baseline Neck Disability Index at 6 months after operation [Before and up to 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.

Secondary Outcome Measures

Change from baseline Numeric rating scale on arm pain at six months after operation [Before and up to 6 months after operation]
Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain
Change from baseline Numeric rating scale on neck pain at six months after operation [Before and up to 6 months after operation]
Numeric rating scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain
Rate of returning to previous leisure activities after operation [Before and up to 6 months 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")
Change from baseline Work Ability Score (WAS) at six months after operation [Before and up to 6 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
The duration of sick leave [Before and after operation]
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

Other Outcome Measures

Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation [Before and at 6 months after operation]
EQ-5D-5L descriptive score ranges from 0 (no problems in health state) to 25 (maximal problem in health state). EQ-5D-5L Visual analogic score (VAS) ranges form 0 (the worst health) to 100 (the best health) assessed by participant.
Patient satisfaction to treatment [at six months after operation]
patients' global assessment of satisfaction to the treatment at six months after operation with this question: "If you were to choose again, would you choose an operative treatment?" ("yes" or "no").
Operative success [at one week, one month, three months and six months after operation]
patient subjectively rates the perception of operative success from poor to excellent by the modified Odom's criteria. the first and second categories ('excellent' and 'good') as a successful outcome of the operation and conversely, last two categories ('fair' and 'poor') as an unsuccessful outcome.
Rate of complications and adverse effects [From operation up to six months postoperatively]
The rate of complications related to intervention or operation in both group after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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