Evidence map›Paper›PMID 39602120›Full record

Trial reportJAMA network open2024

Ambulatory Care vs Overnight Hospitalization After Anterior Surgery for Cervical Radiculopathy: The FACADE Randomized Clinical Trial.

Kimmo Lönnrot, Simo Taimela, Jarno Satopää, Ilkka Saarenpää, Ville Leinonen, Juri Kivelev, Marja Silvasti-Lundell, Johannes Förster, Mikko Pitkänen, Rahul Raj and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA network open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03979443 (Finnish Trial on Practices of Anterior Cervical Decompression and Fusion), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03979443 nacompletednot on this map

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

TypeinterventionalSponsorHelsinki University Central HospitalRan2019 to 2021Enrolled104ConditionsCervical RadiculopathyArmsDischarge on the day of surgery
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. What's New in Spine Surgery.The Journal of bone and joint surgery. American volume · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Kimmo LönnrotDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Simo TaimelaFinnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland.
Jarno SatopääDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Ilkka SaarenpääNeurocenter, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland.
Ville LeinonenDepartment of Neurosurgery, Kuopio University Hospital, Kuopio, Finland.
Juri KivelevNeurocenter, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland.
Marja Silvasti-LundellDepartment of Anesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland.
Johannes FörsterDepartment of Anesthesia, Orthopedic Hospital Orton, Helsinki, Finland.
Mikko PitkänenDepartment of Anesthesia, Orthopedic Hospital Orton, Helsinki, Finland.
Rahul RajDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Mikko KauppinenResearch Unit of Clinical Neuroscience, University of Oulu, Oulu, Finland.
Riitta WestermarckDivision of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Turku, Finland.
Behnam Rezai JahromiDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Anniina Koski-PalkénDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Matti SeppäläDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Leena KivipeltoDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Jussi AntinheimoDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Miikka KorjaDepartment of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Tomasz CzubaDepartment of Clinical Sciences, Orthopaedics, Lund University, Lund, Sweden.
Teppo L N JärvinenFinnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: During the past decade, spinal surgical procedures have been increasingly performed on an ambulatory basis, a change in clinical practice supported only by observational evidence thus far. There have been no randomized clinical trials (RCTs) comparing ambulatory care with inpatient care after any spinal surgery. Objective: To assess whether ambulatory care is noninferior to overnight hospital surveillance in functional outcome, as measured by Neck Disability Index (NDI), in adults after anterior cervical decompression and fusion (ACDF) for cervical radiculopathy. Design, Setting, and Participants: This parallel group, noninferiority RCT enrolled patients at 3 tertiary neurosurgical centers in Finland (University Hospitals of Helsinki, Turku, and Oulu) between June 2019 and February 2021, with a final follow-up in October 2021. Patients aged 18 to 62 years who underwent 1-level or 2-level ACDF due to cervical radiculopathy were assessed for eligibility. After surgery, participants were randomly assigned to either ambulatory care or overnight hospital surveillance. Intention-to-treat data analyses were conducted in August 2022. Interventions: Patients randomly assigned to ambulatory care were kept under surveillance for 6 to 8 hours after surgery and then discharged. Patients assigned to overnight hospital surveillance were kept in the ward for 24 hours or longer. Main Outcomes and Measures: The primary outcome was NDI at 6 months. A minimal important difference of 17.3 percentage points for NDI was set as the margin of noninferiority. Results: Among the 105 patients (mean [SD] age, 47.0 [7.9] years; 54 women [50%]) randomly assigned to ambulatory care (n = 52) or overnight hospital surveillance (n = 53), 94 (90%) completed the trial. Four (8%) patients who received ambulatory care crossed over to overnight hospital surveillance. Seventy-nine patients (75%) had a 1-level ACDF and 26 (25%) had a 2-level ACDF. At 6 months after surgery, the mean NDI was 13.3% (95% CI, 9.3%-17.3%) in the ambulatory care group and 12.2% (95% CI, 8.2%-16.2%) in the overnight hospital surveillance group (between-group mean difference, 1.1 [95% CI, -4.6 to 6.8] percentage points). Conclusions and Relevance: In this RCT comparing functional outcomes of ambulatory care vs overnight hospital surveillance after ACDF, ambulatory care resulted in noninferior functional outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03979443.

Indexed as

Ambulatory CareRadiculopathyAdultCervical VertebraeDecompression, SurgicalFemaleFinlandHospitalizationHumansMaleMiddle AgedSpinal FusionTreatment Outcome

Identifiers

PMID39602120
PMCPMC12124692

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.