Autologous Growth Factor-Rich Concentrate (GFC) Injection in Non-union of Fractures: A Quasi-experimental Study.

Introduction: Non-union fractures represent a significant challenge in orthopedic practice, contributing to considerable morbidity and socioeconomic burden. Traditional treatments, such as autologous bone grafting, are effective but have limitations, including donor-site morbidity and limited tissue availability. Autologous peripheral blood-derived orthobiologics, including growth factor-rich concentrate (GFC), have emerged as a minimally invasive alternative, leveraging the body's natural healing mechanisms by concentrating and applying growth factors directly to the fracture site. This study evaluates the safety and efficacy of GFC injections in the treatment of non-union fractures.

Materials and methods: This quasi-experimental study included 17 patients with non-union fractures of various long bones, treated under fluoroscopic guidance with three doses of 5 mL GFC injections, administered 2 weeks apart at the non-union site. Demographic data, injury characteristics, and comorbid conditions were recorded. Growth factor levels were quantified via enzyme-linked immunosorbent assay (ELISA), and statistical analyses were conducted to explore associations between the amount of growth factors and treatment outcomes. Radiographic assessments and bony callus appearance were evaluated at the baseline and at 1-, 3-, and 6-month follow-up post-last injection.

Results: No adverse effects were reported throughout the duration of the study. The majority of patients (82.4%) showed significant improvement, evidenced by enhanced bony callus formation and reduced non-union signs. No significant correlation was found between the specific growth factor levels and the clinical outcomes of non-union of fractures. However, the presence of comorbid conditions significantly influenced treatment efficacy, underscoring the importance of patient selection in clinical practice.

Conclusion: Administration of GFC injection is safe and potentially efficacious for the treatment of non-union fractures, offering an alternative to traditional surgical interventions. These results laid the foundation for prospective, adequately powered, randomized and non-randomized clinical studies with longer follow-up to further establish the efficacy of GFC in patients with non-union fractures. Moreover, formulation protocols need to be optimized while considering patient-specific variables, to ensure reproducibility and repeatability of outcomes from these studies.

Supplementary information: The online version contains supplementary material available at 10.1007/s43465-024-01278-1.