Introduction: Following osteosynthesis, children generally require a second surgery to remove the hardware. This becomes unnecessary, by using resorbable implants. Limiting the number of required surgeries and their associated risks, this technique provides critical aspects of minimally invasive surgery. This review focuses on resorbable implants for osteosynthesis for the treatment of fractures in children and discusses their clinical features. Method: We provide an overview of the two most common technologies used in resorbable osteosynthesis materials: polymer- and magnesium-based alloys. Clinical examples of osteosynthesis are presented using polymer-based ActivaTM products and magnesium-based Magnezix® products. Results: Polymer-based implants demonstrate surgical safety and efficacy. Due to their elasticity, initial placement of polymer-based products may demonstrate technical challenges. However, stability is maintained over the course of healing. While maintaining good biocompatibility, the rate of polymer-resorption may be controlled by varying the composition of polyesters and copolymers. Similarly, magnesium-based implants demonstrate good mechanical stability and resorption rates, while these characteristics may be controlled by varying alloy components. One of the significant shortcomings of magnesium is that metabolism results in the production of hydrogen gas. Both technologies provide equally good results clinically and radiographically, when compared to non-resorbable implants. Conclusion: Resorbable osteosynthesis materials demonstrate similar therapeutic results as conventional materials for osteosynthesis. Resorbable implants may have the potential to improve patient outcomes, by sparing children a second surgery for hardware removal.
Background: Distal radius fractures are very common in paediatric patients. Severely displaced fractures may require surgical intervention. The gold standard surgical method is percutaneous K-wire osteosynthesis followed by immobilisation. Metal implants can be removed with a second intervention; however, these extra procedures can cause further complications. Several studies confirm the benefits of bioabsorbable implants for paediatric patients. The aim of this retrospective study was to compare the complication rates of displaced distal metaphyseal radius (AO 23r-M/3.1) and forearm (AO 23-M/3.1) fractures in children operated on with K-wires versus a novel technique with bioresorbable implants. Methods: We retrospectively reviewed 94 patients in three paediatric trauma centres who underwent operations due to severely displaced distal forearm or metaphyseal radial fractures between January 2019 and January 2020. The mean age was 8.23 (ranging from 5–12). 30 patients (bioresorbable group, BR-group) were treated with biodegradable PLGA implants (Bioretec®, ActivaPin®), 40 patients with one or two stainless steel Kirschner-wires (K-wires, Sanatmetal®) which were buried under the skin (KW I-group) and 24 children with K-wires left outside the skin. (KWII. Group). We examined the number of minor and major complications as well as the need for repeated interventions. Follow-up was at least one and half year. Results: There was no significant difference between the complication rates at the two KW groups (p = 0.241; Cramer’s V = 0.211), while the complication rate of the BR group was significantly lower. (p = 0.049; Cramer’s V = 0.293 and p = 0.002; Cramer’s V = 0.418 respectively). No later than half a year after the injury, no difference was observed between the functional outcomes of the patients in each group. One and a half years after the injury, no signs of growth disturbance were found in any of the children. No second surgical intervention was required in the BR group. Conclusions: Surgeries with bioresorbable intramedullary implants may have fewer complications than K- wire osteosynthesis in the treatment of severely displaced distal forearm fractures. The benefits are most pronounced in the first six weeks after surgery, reducing the number of outpatient visits and increasing the child's sense of comfort. As no second intervention is required, this can lead to significant cost savings. After half a year, there is no difference in the outcomes between the different surgical treatment strategies.
(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, 15–119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2–18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 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.
Medial humeral epicondyle fractures account for 10% to 20% of elbow injuries in children. We hypothesized that in the fixation of medial humeral epicondyle fractures, safety and efficiency of bioabsorbable poly(l-lactide-co-glycolic acid) implant are comparable to traditional metallic and other novel approaches. A retrospective cohort study was performed between 2016 and 2019, analyzing 24 children who had medial humeral epicondyle fractures. Every fracture was stabilized with biodegradable poly(l-lactide-co-glycolic acid) implants (Bioretec® ActivaPin®) and tension band polydioxanone sutures. Indications for surgery included closed fractures with >1 cm dislocation and incarcerated fractures. Postoperatively, the degree of anatomic reduction and the presence or absence of nonunion or fragmentation were confirmed with X-rays. In this clinical study, we evaluated the operation time, age, and gender distribution. The mean age at the time of injury was 12.3 (8–16 years). In the fourth week, every patient’s X-ray showed callus formation, and the range of motion of the elbow after 6 months of the operation was almost complete in all children. Transient ulnar nerve palsy was developed in 1 patient, which was spontaneously resolved in the fourth postoperative month. No other complications were observed during the average follow-up period of 34 months (16–60 months). Bioabsorbable pins with absorbable sutures are a good alternative treatment of medial epicondyle humeral fracture. No permanent complications were noted while using this technique. We suggest this method because it does not require a secondary (metal removal) operation.