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

Cervical Radiculopathy Clinical Trial

— FACADE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979443
• Other study ID #: 1540/2019
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Oulu University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six 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.	Before and at 6 months after operation
Other	Patient satisfaction to treatment	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").	at six months after operation
Other	Operative success	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.	at one week, one month, three months and six months after operation
Other	Rate of complications and adverse effects	The rate of complications related to intervention or operation in both group after operation	From operation up to six months postoperatively
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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