Helsinki University Hospital
Helsinki, Finland
NCT Number: NCT03979443
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.
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Notify Me18 year–62 year
All sexes
Interventional
Not applicable
Helsinki, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
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.
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
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
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")
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
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
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.
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").
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.
Time frame: From operation up to six months postoperatively
The rate of complications related to intervention or operation in both group after operation
Helsinki University Central Hospital
Other
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
Acronym: FACADE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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