Cervical RadiculopathyFACADENCT03979443
Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care
A study testing Discharge on the day of surgery in people with Cervical Radiculopathy, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Discharge on the day of surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFinland
- Study dates
- 12 Jun 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Discharge on the day of surgery
- Keywords
- Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol
- Medical subject headings
- Radiculopathy, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge on the day of surgeryProcedure or surgery
Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Discharge on the day of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and up to 6 months after operation
Secondary outcomes (5)
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
Measured: Before and up to 6 months after operation
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
Measured: 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")
Measured: 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
Measured: 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
Measured: Before and after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start12 Jun 2019
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital
- Responsible party
- Principal investigator, Kimmo Lonnrot, Helsinki University Central Hospital
- Investigators
- Kimmo Lonnrot, MD, PhD, Principal investigator, Senior neurosurgeon at Helsinki Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979443
- Sponsor's protocol ID
- 1540/2019
- Acronym
- FACADE
- Status last verified
- Mar 2023
- First submitted
- 4 Jun 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Publications
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.
PubMed 39602120Lonnrot 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.
PubMed 31772100
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03979443
- Acronym / sponsor ID
- FACADE / 1540/2019
- Conditions
- Cervical Radiculopathy
- Keywords
- Anterior cervical decompression and fusion, cervical fusion, cervical spine, spinal surgery, outpatient care, randomized controlled trial, Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient | No intervention | –patients staying in the hospital for 1-3 nights after surgery |
| Outpatient | Active comparator | Procedure: Discharge on the day of surgerydischarge on the day of the surgery, usually within 6-8 hours after procedure |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge on the day of surgeryPatient discharge on the day of the surgery, usually within 6-8 hours after procedure | Procedure or surgery | Outpatient |
Primary outcome
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.
5 secondary outcomes
Change from baseline Numeric rating scale on arm pain at six months after operation
Time frame: Before and up to 6 months after operation
Change from baseline Numeric rating scale on neck pain at six months after operation
Time frame: Before and up to 6 months after operation
Rate of returning to previous leisure activities after operation
Time frame: Before and up to 6 months after operation
Change from baseline Work Ability Score (WAS) at six months after operation
Time frame: Before and up to 6 months after operation
The duration of sick leave
Time frame: Before and after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 39602120Lonnrot 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.
- Derived from this study: PubMed 31772100Lonnrot 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimmo Lonnrot, MD, PhD principal investigator
Senior neurosurgeon at Helsinki Univ. Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge on the day of surgery in people with Cervical Radiculopathy, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Neck Disability Index at 6 months after operation (time frame: Before and up to 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.