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

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Discharge on the day of surgery
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Inpatient

Outpatient

Arm Description

patients staying in the hospital for 1-3 nights after surgery

discharge on the day of the surgery, usually within 6-8 hours after procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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")
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
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

Full Information

First Posted
June 4, 2019
Last Updated
March 21, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03979443
Brief Title
Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inpatient
Arm Type
No Intervention
Arm Description
patients staying in the hospital for 1-3 nights after surgery
Arm Title
Outpatient
Arm Type
Active Comparator
Arm Description
discharge on the day of the surgery, usually within 6-8 hours after procedure
Intervention Type
Procedure
Intervention Name(s)
Discharge on the day of surgery
Intervention Description
Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
Primary Outcome Measure Information:
Title
Change from baseline Neck Disability Index at 6 months after operation
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline Numeric rating scale on arm pain at six months after operation
Description
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
Title
Change from baseline Numeric rating scale on neck pain at six months after operation
Description
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
Title
Rate of returning to previous leisure activities after operation
Description
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
Title
Change from baseline Work Ability Score (WAS) at six months after operation
Description
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 up to 6 months after operation
Title
The duration of sick leave
Description
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 after operation
Other Pre-specified Outcome Measures:
Title
Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation
Description
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
Before and at 6 months after operation
Title
Patient satisfaction to treatment
Description
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 six months after operation
Title
Operative success
Description
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
at one week, one month, three months and six months after operation
Title
Rate of complications and adverse effects
Description
The rate of complications related to intervention or operation in both group after operation
Time Frame
From operation up to six months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms Neck Disability Index score ≥30 out of 100 Age between 18 to 62 years No previous cervical operations Currently employed No co-morbidities causing a need for a sick leave Provision of informed consent from the participant No contraindication for randomization in postoperative check (see below) Exclusion Criteria: MRI finding inconsistent with patient's symptoms Diagnosed osteoporosis or permanent use of oral corticosteroids ACDF operation requiring plate or cage fixation with screws Active malignancy American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients) Pregnancy Abundant use of alcohol, drugs or narcotics No possibility to be accompanied by an adult person over the first postoperative night after the surgery Insufficient Finnish language skills Distance to the closest hospital emergency more than 60 min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo Lonnrot, MD, PhD
Organizational Affiliation
Senior neurosurgeon at Helsinki Univ. Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
IPD Sharing 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.
IPD Sharing Access Criteria
Data access request will be reviewed by FACADE steering group. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
31772100
Citation
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.
Results Reference
derived

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

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