Helsinki-based Bioretec designed the ActivaPin implants for pediatric patients to treat severely displaced distal radius and forearm fractures.
According to a news release, the results from the retrospective, multicenter study demonstrated that patients treated with ActivaPin has a significantly lower level of complications compared to those treated with traditional, non-biodegradable, metallic Kirschner-wires (k-wires), while no second surgical intervention was required.
Bioretec comprised the ActivaPin implant of bioresorbable polymer (PLGA), which safely disappears in the body in approximately two years. The company aims to offer ActivaPin as an alternative to the standard of care using k-wires. Percutaneous k-wire osteosynthesis followed by immobilization can often require removal surgery for the metal implants that can cause further complications, Bioretec said.
The study of 94 patients across three pediatric trauma centers found that the complication rate of the ActivaPin group was significantly lower than that of the k-wire group, with no major complications associated with ActivaPin and no signs of growth disturbance in any of the children after 18-month follow-up.
“The results of the study are very encouraging. The novel surgical technique leads to less complications and also offers major advantages to surgeons,” Bioretec CEO Timo Lehtonen said in the release. “The benefits of ActivaPin were most pronounced in the first six weeks after surgery: the number of outpatient visits were reduced, and children’s sense of comfort was increased. In addition, avoiding second surgical intervention results in significant cost savings. And most importantly, children can return to their normal everyday life and activities faster.”