Informed Consent in Orthopaedic Surgery: When a Signature Does Not Mean Understanding: A Prospective Study of 750 Patients Comparing Elective and Trauma Settings.

backgroundInformed consent is a cornerstone of modern medicine, yet the extent to which patients truly understand surgical information in the perioperative setting remains uncertain, particularly among older and vulnerable populations. Orthopaedic surgery represents a particularly challenging context, as trauma pathways are often characterized by urgency, pain, and emotional stress, whereas elective procedures allow greater opportunity for structured communication.

aimsTo assess real-time patient comprehension of surgical informed consent immediately before orthopaedic surgery and to compare understanding between elective and trauma pathways.

methodsWe conducted a prospective observational study at a single tertiary referral hospital in Northern Italy between January 2023 and December 2024. Approximately 870 adult orthopaedic surgical patients were screened for eligibility. After exclusion of patients with cognitive impairment, severe psychiatric illness, language barriers, refusal to participate, or incomplete questionnaires, 750 consecutive patients were included in the final analysis (460 elective, 290 trauma). All patients had received standard preoperative explanations and completed institutional informed consent procedures. In routine clinical practice, consent discussions generally involved both an orthopaedic resident and the supervising attending surgeon. Comprehension was assessed immediately before transfer to the operating room using a brief standardized four-item tool evaluating understanding of the planned procedure, risks, benefits, and therapeutic alternatives. Responses were independently categorized as absent, vague/partial, or adequate.

resultsOverall, 488 patients (65.1%) demonstrated absent comprehension, 188 (25.1%) vague or partial comprehension, and only 74 (9.9%) adequate comprehension. Trauma patients showed significantly lower overall comprehension than elective patients, with fewer patients demonstrating at least partial comprehension (28.3% vs. 39.1%; p = 0.003). Adequate comprehension remained low in both groups (8.3% vs. 10.9%; p = 0.30). Older age and lower educational attainment were associated with poorer comprehension in exploratory analyses. Mean questionnaire completion time was 3.5 ± 1.2 min. DISCUSSION: Despite repeated explanations and signed consent forms, most patients entered the operating room without meaningful understanding of the planned procedure, risks, benefits, or alternatives. The observed deficit was present in both elective and trauma settings, suggesting a systemic limitation of routine consent processes rather than solely a physician-specific communication issue.

conclusionsInformed consent in orthopaedic surgery frequently fails to ensure patient comprehension. Consent should be reframed as a dynamic verification process rather than a purely administrative requirement, incorporating structured communication pathways, simplified language, and teach-back-based strategies tailored to both elective and trauma settings.