Retrieval and clinical analysis of distraction-based dual growing rod constructs for early-onset scoliosis

BACKGROUND CONTEXT: Growing rod constructs are an important contribution for treating patients with early-onset scoliosis. These devices experience high failure rates, including rod fractures. PURPOSE: The objective of this study was to identify the failure mechanism of retrieved growing rods, and to identify differences between patients with failed and intact constructs. STUDY DESIGN/SETTING: Growing rod patients who had implant removal and were previously enrolled in a multicenter registry were eligible for this study. PATIENT SAMPLE: Forty dual-rod constructs were retrieved from 36 patients across four centers, and 34 of those constructs met the inclusion criteria. Eighteen constructs failed due to rod fracture. Sixteen intact constructs were removed due to final fusion (n=7), implant exchange (n=5), infection (n=2), or implant prominence (n=2). OUTCOME MEASURES: Analyses of clinical registry data, radiographs, and retrievals were the outcome measures. METHODS: Retrievals were analyzed with microscopic imaging (optical and scanning electron microscopy) for areas of mechanical failure, damage, and corrosion. Failure analyses were conducted on the fracture surfaces to identify failure mechanism(s). Statistical analyses were performed to determine significant differences between the failed and intact groups. RESULTS: The failed rods fractured due to bending fatigue under flexion motion. Construct configuration and loading dictate high bending stresses at three distinct locations along the construct: (1) mid-construct, (2) adjacent to the tandem connector, or (3) adjacent to the distal anchor foundation. In addition, high torques used to insert set screws may create an initiation point for fatigue. Syndromic scoliosis, prior rod fractures, increase in patient weight, and rigid constructs consisting of tandem connectors and multiple crosslinks were associated with failure. CONCLUSION: This is the first study to examine retrieved, failed growing rod implants across multiple centers. Our analysis found that rod fractures are due to bending fatigue, and that stress concentrations play an important role in rod fractures. Recommendations are made on surgical techniques, such as the use of torque-limiting wrenches or not exceeding the prescribed torques. Additional recommendations include frequent rod replacement in select patients during scheduled surgeries. Published by Elsevier Inc.