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

Not Applicable

Completed

• Conditions: Cervical Radiculopathy
• Interventions: Procedure: Discharge on the day of surgery

• Registration Number: NCT03979443
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-06-12
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient	Discharge on the day of surgery	discharge on the day of the surgery, usually within 6-8 hours after procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland