Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients

Abstract

PurposeIdentification of all common and potentially avoidable adverse events is crucial to further improve the quality of medical care. The intention of the current study was to evaluate a standardized physician independent survey format on adverse events in total knee arthroplasty. The protocol for reporting adverse drug events following the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) was adopted for adverse events occurring during surgical interventions.Material and methodsData of a prospective sequential cohort trial introducing a clinical pathway for total knee arthroplasty was analysed. Reporting of adverse events was done by a physician independent study nurse using the modified ICH-Good Clinical Practice (GCP) format (Structure and Content of Clinical study reports - E3) in 260 patients. The adverse events were graded to their severity and their potential relation to surgical treatment.ResultsA total of 55 patients (21%) suffered from an adverse event and 16 (6%) from a serious adverse event. In 38 patients' one adverse event occurred, 12 patients showed 2 adverse events and 5 patients suffered from a combination of an adverse and a serious adverse event. A serious adverse event alone occurred in 11 patients. The incidence of adverse events (Fisher p = 0.448) and serious adverse (p = 0.126) events showed no significant difference between the two cohorts. The most common adverse events were deep vein thrombosis (8% and 5%) followed by wound healing problems (1% and 0%) and haematoma (1% and 3%). A wide range of non surgical adverse events were recorded with low incidence levels.ConclusionThe use of the modified ICH-GCP format supports standardization of adverse event reporting. Routine assessment of adverse events by a study nurse revealed higher incidence rates of adverse events in total knee arthroplasty. We recommend the implementation of trained paramedical staff for the documentation of adverse events in routine clinical care.

A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions

“…Our findings are consistent with prior investigations demonstrating a favorable safety profile for the percutaneous use of BMC and MSC injections for the treatment of orthopaedic conditions of the peripheral and axial joints and surrounding tissues [7,9,13,14]. The SAE rates observed in our study were substantially lower than those reported for more invasive orthopaedic surgical procedures [22]. As an example, the SAE rate for total knee arthroplasty among 260 patients at three months follow-up was 6 % [22].…”

“…The SAE rates observed in our study were substantially lower than those reported for more invasive orthopaedic surgical procedures [22]. As an example, the SAE rate for total knee arthroplasty among 260 patients at three months follow-up was 6 % [22]. In comparison, there were 13 possibly related SAEs in the present study Fig.…”

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“…The number of adverse events was as expected in this age group undergoing a high-risk surgery if standardised assessment is performed [16]. It is, however, relatively high compared to many other studies in which adverse events are often not defined and not assessed in a standardised manner [10].…”

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“…In a US study including > 950,000 patients with joint replacement, the in-hospital rate of serious postoperative adverse events including infection, non-healing wounds, pulmonary embolism and vascular complications was 2.6%. 36 In 260 patients with knee replacement, Kirschner and colleagues 176 reported that 6% of patients had serious adverse events within 3 months of knee replacement. More general adverse events occurred in a further 26% of patients.…”