
OrthoPediatrics Launches New Functional Brace for Pediatric Femur Fracture; Data Shows Cost Benefits, Ability to Prevent General Anesthesia
OrthoPediatrics Corp., a company dedicated to advancing the field of pediatric orthopedics, has recently unveiled a new innovation for pediatric patients with musculoskeletal injuries with the limited release of the DF2® Brace. This is OrthoPediatrics first expansion into non-surgical orthopedic products for children.
The DF2® Brace has been specifically designed for the fixation of femur fractures in pediatric patients ranging from approximately 6 months to 5 years of age. Instead of traditional spica casts, the brace offers effective immobilization of the femur, knee, and hip for young patients with musculoskeletal injuries.
For years, spica casts have been the gold standard for femur fracture treatment, with a track record dating back decades. The DF2® Brace signifies a potential improvement in the management of femur fractures in children. The brace underwent rigorous testing and was assessed in a multi-center trial. Recent data on functional braces have demonstrated their cost effectiveness and ability to provide similar outcomes while preventing the need for general anesthesia.
One study published in 2022 in the Journal of the Pediatric Orthopedic Society of North America compared the outcomes of pediatric patients aged 6 months to 5 years with diaphyseal femur fractures treated with prefabricated functional braces versus traditional spica casting, which is currently recommended by the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. In the study conducted at two pediatric centers, a total of 56 patients (29 treated with spica casting and 27 with braces) were included with a mean age of patients in both groups of 2.3 years. The results at 6 weeks post-treatment revealed that all fractures had successfully achieved union. There were no significant differences between the two groups in terms of femoral shortening or varus angulation. However, the spica group showed higher mean procurvatum (bending forward) than the brace group, which was statistically significant. Importantly, there were no malunions in either group, highlighting the efficacy of both treatment methods. Twenty patients had a one-year follow-up (11 from the spica group and 9 from the brace group), and at this point, the study found no significant differences in femoral shortening, varus angulation, or procurvatum. All patients were ambulatory, except for one who had suffered a new ankle fracture. The prospective randomized trial demonstrated that patients treated with functional bracing had outcomes equivalent to those treated with spica casting, and they also offer the advantage of avoiding the costs and anesthesia associated with spica casting in the operating room.
Joe Hauser, President of Trauma and Deformity Correction at OrthoPediatrics, expressed his enthusiasm about this groundbreaking development. He emphasized the positive impact it would have on the treatment of children with femur fractures, stating, “This is the first product launch for the OrthoPediatrics Specialty Bracing group and will significantly improve the care of kids with femur fractures. The ability to eliminate anesthesia and complications associated with spica casts, all while reducing the overall cost of care is a significant advancement in pediatric orthopedics for patients, their families, and surgeons.”