FACADE
Trial question
Is ambulatory care noninferior to overnight hospital surveillance in patients after anterior cervical decompression and fusion for cervical radiculopathy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 105
105 patients (54 female, 51 male).
Inclusion criteria: adult patients aged 18-62 years who underwent anterior cervical decompression and fusion for cervical radiculopathy.
Key exclusion criteria: cervical myelopathy; unemployment; comorbidities necessitating extended sick leave or previous cervical operation; active malignancy; pregnancy; use of alcohol, drugs, or narcotics.
Interventions
N=52 ambulatory care (care with discharge 6-8 hours after anterior cervical decompression and fusion for cervical radiculopathy).
N=53 overnight hospital surveillance (surveillance for ≥ 24 hours after anterior cervical decompression and fusion for cervical radiculopathy).
Primary outcome
Neck Disability Index at 6 months
13.3%
12.2%
13.3 %
10.0 %
6.7 %
3.3 %
0.0 %
Ambulatory
care
Overnight hospital
surveillance
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in Neck Disability Index at 6 months (13.3% vs. 12.2%; MD 1.1, 95% CI -4.6 to 6.8).
Secondary outcomes
No significant difference in arm pain at 6 months (1.7% vs. 1.6%; MD 0.1, 95% CI -0.8 to 1).
No significant difference in neck pain at 6 months (2.1% vs. 1.8%; MD 0.3, 95% CI -0.7 to 1.2).
No significant difference in return to previous activities at 6 months (82% vs. 92%; MD -10, 95% CI -25 to 4).
Conclusion
In adult patients aged 18-62 years who underwent anterior cervical decompression and fusion for cervical radiculopathy, ambulatory care was noninferior to overnight hospital surveillance with respect to Neck Disability Index at 6 months.
Reference
Kimmo Lönnrot, Simo Taimela, Jarno Satopää et al. 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.
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