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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979443
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : March 16, 2022
Sponsor:
Collaborators:
Turku University Hospital
Oulu University Hospital
Information provided by (Responsible Party):
Kimmo Lonnrot, 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.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Procedure: Discharge on the day of surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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")

  4. 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

  5. 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


Other Outcome Measures:
  1. 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.

  2. 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").

  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Finland
Helsinki University Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Turku University Hospital
Oulu University Hospital
Investigators
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Principal Investigator: Kimmo Lonnrot, MD, PhD Senior neurosurgeon at Helsinki Univ. Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kimmo Lonnrot, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03979443    
Other Study ID Numbers: 1540/2019
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: Data access request will be reviewed by FACADE steering group. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimmo Lonnrot, Helsinki University Central Hospital:
Anterior cervical decompression and fusion
cervical fusion
cervical spine
spinal surgery
outpatient care
randomized controlled trial
Protocol
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases