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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| Oulu University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient | No Intervention | patients staying in the hospital for 1-3 nights after surgery | |
| Outpatient | Active Comparator | discharge on the day of the surgery, usually within 6-8 hours after procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discharge on the day of surgery | Procedure | Patient discharge on the day of the surgery, usually within 6-8 hours after procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline Numeric rating scale on neck pain at six months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimmo Lonnrot, MD, PhD | Senior neurosurgeon at Helsinki Univ. Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39602120 | Derived | Lonnrot K, Taimela S, Satopaa J, Saarenpaa I, Leinonen V, Kivelev J, Silvasti-Lundell M, Forster J, Pitkanen M, Raj R, Kauppinen M, Westermarck R, Jahromi BR, Koski-Palken A, Seppala M, Kivipelto L, Antinheimo J, Korja M, Czuba T, Jarvinen TLN. Ambulatory Care vs Overnight Hospitalization After Anterior Surgery for Cervical Radiculopathy: The FACADE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2447459. doi: 10.1001/jamanetworkopen.2024.47459. | |
| 31772100 |
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Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Study protocol and Statistical Analysis Plan (SAP) will be published after the study has started. Other document will be available as study proceeds and after study is completed.
Data access request will be reviewed by FACADE steering group. Requestors will be required to sign a Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2022 | Aug 17, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004413 | Dysostoses |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Derived |
| Lonnrot K, Taimela S, Toivonen P, Aronen P, Koski-Palken A, Frantzen J, Leinonen V, Silvasti-Lundell M, Forster J, Jarvinen T; FACADE investigators. Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care. BMJ Open. 2019 Nov 26;9(11):e032575. doi: 10.1136/bmjopen-2019-032575. |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |