Complication reporting and assessment is an important part of orthopaedic trials assessing new technologies. Because the reliability of the assessment by the treating surgeon compared to central review is still unknown, it was quantified in this study and possible patterns were identified. 176 patients with trochanteric fractures, treated with a trochanteric nail, were included in a prospective multicenter study. Surgeons were encouraged to report honestly every single potential complication, to rate severity, most likely cause, relation to implant, and to report the outcome of the complication. After 1-yr follow-up, 3 experienced orthopedic surgeons reassessed independently the same variables (agreement determined using kappa coefficient). Discrepancies were resolved by consensus.Introduction
Materials and methods
