A recently published clinical study confirms the benefits of using fully bioresorbable ActivaPin implant together with bioabsorbable suture, for the tension band wire treatment of pediatric medial epicondyle humeral fractures. A tension band wire is a form of orthopaedic internal fixation method used to convert distraction forces into compression forces, promoting bone healing. The results of the retrospective cohort study shows that patients treated with bioresorbable ActivaPin were provided a good alternative treatment against traditional non-biodegradable metallic implants but without a need for second surgical intervention (i.e. metal implant removal).
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Medial humeral epicondyle fractures account for 10% to 20% of elbow injuries in children. According to the study, the safety and efficiency of bioabsorbable implant is comparable to other novel approaches and traditional metallic implants. However, the non-biodegradable metal implants often require removal surgery that can cause even further complications. The ActivaPin implant is made of self-reinforced bioresorbable polymer (PLGA), which safely disappears in the body in approximately two years.
In the study, a total of 24 consecutive patients were retrospectively reviewed between January 2016 and January 2019. The patients underwent operations due to medial humeral epicondyle fractures and were treated with bioresorbable ActivaPin along with tension band polydioxanone sutures. Postoperatively, the clinical outcome was confirmed in different follow up time points with X-rays . At 4 weeks, all patients showed callus formation on the X-ray. By the third postoperative month, the range of motion of the elbow was complete in 22 patients, and the other 2 children regained their full range of movement by the sixth month. No growth disturbance, necrosis, or axial malalignment were observed during the follow-up period of 16 – 60 months, neither any nonunion nor delayed union.
“One of the corner stones of Bioretec‘s strategy is to provide strong clinical evidence of the company’s bioresorbable products. Again, we are able to present a safe and efficient surgical technique using fully bioresorbable products for the benefit of the patients. The traditional surgical method with non-bioresorbable products for the treatment of pediatric humeral epicondyle fractures leads to removal operations. According to the authors, many surgeons routinely remove implants from children because they do not want to leave them in the growing bone, and general anesthesia associated with secondary surgery may be a source of additional potential complications. Once more, as secondary operation is not needed with our products, children can return to their normal everyday life and activities faster,” says Timo Lehtonen, CEO of Bioretec, a globally operating Finnish medical device company and a pioneer in bioresorbable orthopedic implants.