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High Failure Rates of a Unilateral Posterior Peri-Apical Distraction Device (ApiFix) for Fusionless Treatment of Adolescent Idiopathic Scoliosis. | LitMetric
Background : Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion.Methods : In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed.Results : Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early.Conclusions : The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval.Level Of Evidence : Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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