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

NCT ID: NCT03979443

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2021-10-30

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inpatient

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Outpatient

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

Group Type: ACTIVE_COMPARATOR

Discharge on the day of surgery

Intervention Type: PROCEDURE

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

Interventions

Discharge on the day of surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Oulu University Hospital

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kimmo Lonnrot

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimmo Lonnrot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior neurosurgeon at Helsinki Univ. Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 39602120 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31772100 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1540/2019

Identifier Type: -

Identifier Source: org_study_id