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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    104
  • sponsor
    Helsinki University Central Hospital
Updated on 11 February 2022
stenosis
MRI
conservative therapy
paresthesia
discectomy
nerve root compression
radiculopathy
cervical radiculopathy

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.

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.

Details
Condition Cervical Radiculopathy
Treatment Discharge on the day of surgery
Clinical Study IdentifierNCT03979443
SponsorHelsinki University Central Hospital
Last Modified on11 February 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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