The Photodynamic Bone Stabilization System in the Treatment of Humerus Fractures: A Prospective Clinical Trial

摘要

Background Fractures of the proximal humerus are among the most common long-bone fractures and present unique challenges to surgeons. Traditional internal fixation methods, such as intramedullary nails, are associated with drawbacks such as an inability to fully fill the trabecular space and a limited ability to utilize supplemental hardware in many cases. We evaluated the safety and effectiveness of a novel fracture fixation device that utilizes a light-cured monomer to stabilize the fracture in a cohort of patients suffering from humerus fractures. Methods We prospectively collected data from patients being treated surgically for humerus fractures. Fractures were treated using the photodynamic bone stabilization system (PBSS) consisting of a balloon and light-cured monomer. Patients were evaluated at 7-14, 30, 60, 90, 180, and 360 days post-procedure. Primary outcomes included normal and complete radiographic fracture healing. Secondary outcomes included pain (via visual analog scale), function (via the disability of the arm, shoulder,?and hand (DASH) and constant shoulder scales), and the rate of complications. Results A total of 33 patients were included in the intent-to-treat analysis (mean age: 76.6 yrs). Of these patients, 88% demonstrated normal radiographic healing at their 90-, 180-, and 360-day visits. Complete radiographic healing was observed in 81%, 88%, and 96% of patients at 90, 180, and 360 days, respectively. Pain scores decreased significantly at day seven when compared with baseline (28.2+20.9 vs.53.6+32.2, p0.001) and continued to decrease at the 90-day (24.7+15.5, p0.001), 180-day (17.8+12.5, p0.001) and 360-day (6.6+6.7, p0.001) evaluations. DASH scores demonstrated statistically significant improvements over baseline (65.5+31.5) at 90 (37.0+14.9, p0.001), 180 (30.6+15.7, p0.001), and 360 days (23.9+15.0, p0.001) post-procedure. The procedure-related event rate was 36.4%, with 5 (11.4%) device-related adverse events reported at the one-year follow-up. Conclusions Our study demonstrates the ability of a novel internal fixation device to safely and effectively treat fractures of the humerus in the elderly population.