mdpichildren Read the High Cited Paper this week! Pilot Study and Preliminary Result

mdpichildren Read the High Cited Paper this week!
Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children

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Abstract 1 Background Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing ESIN is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail. Among other objectives, the rate of refracture will be determined. 2 Methods An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. 3 Results As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls 40.8 and 45 boys 59.2. The mean age at the time of inclusion was 8.9 years 2.4 years. The mean operation time was 58.9 22.9 min range, 15119 min. The mean follow-up time was 8.9 5.1 months range, 0.218.6. Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery 176 1.3. 4 Conclusion The research project assesses the safety and effectiveness of Activa IM-Nails as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available.

fracture children forearm intramedullarynailing bioabsorbable

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