NCT03979443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 12, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

June 4, 2019

Last Update Submit

March 21, 2023

Conditions

Cervical Radiculopathy

Keywords

Anterior cervical decompression and fusioncervical fusioncervical spinespinal surgeryoutpatient carerandomized controlled trialProtocol

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change from baseline Numeric rating scale on arm pain at six months after operation

    Before and up to 6 months after operation

  • Change from baseline Numeric rating scale on neck pain at six months after operation

    Before and up to 6 months after operation

  • Rate of returning to previous leisure activities after operation

    Before and up to 6 months after operation

  • Change from baseline Work Ability Score (WAS) at six months after operation

    Before and up to 6 months after operation

  • The duration of sick leave

    Before and after operation

Other Outcomes (4)

  • Change from baseline Euroqol 5 dimensional questionnaire of generic quality of life measurement (EQ-5D-5L) at six months after operation

    Before and at 6 months after operation

  • Patient satisfaction to treatment

    at six months after operation

  • Operative success

    at one week, one month, three months and six months after operation

  • +1 more other outcomes

Study Arms (2)

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

Procedure: Discharge on the day of surgery

Interventions

Discharge on the day of surgeryPROCEDURE

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

Outpatient

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (2)

  • 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.

    PMID: 39602120DERIVED

  • 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.

    PMID: 31772100DERIVED

MeSH Terms

Conditions

RadiculopathyKlippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kimmo Lonnrot, MD, PhD

    Senior neurosurgeon at Helsinki Univ. Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 7, 2019

Study Start

June 12, 2019

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

FI(1)