Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care (FACADE)
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|ClinicalTrials.gov Identifier: NCT03979443|
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : March 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cervical Radiculopathy||Procedure: Discharge on the day of surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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 :||June 12, 2019|
|Actual Primary Completion Date :||October 30, 2021|
|Actual Study Completion Date :||October 30, 2021|
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
- Change from baseline Neck Disability Index at 6 months after operation [ Time Frame: 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.
- Change from baseline Numeric rating scale on arm pain at six months after operation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From operation up to six months postoperatively ]The rate of complications related to intervention or operation in both group after operation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979443
|Helsinki University Hospital|
|Principal Investigator:||Kimmo Lonnrot, MD, PhD||Senior neurosurgeon at Helsinki Univ. Hospital|