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NCT Number: NCT03979443

Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discharge on the day of surgery

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Oulu University Hospital
  • Turku University Hospital

Registry information

Official study 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

Acronym: FACADE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2019
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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