Complication Reporting in Orthopaedic Trials

Goldhahn, Sabine; Sawaguchi, Takahiro; Audigé, Laurent; Mundi, Raman; Hanson, Beate; Bhandari, Mohit; Goldhahn, Jörg

doi:10.2106/jbjs.h.01455

Cited by 60 publications

(16 citation statements)

References 23 publications

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“…In their analysis of the general orthopedics literature, Goldhahn et al 33 concluded that clinical trials in orthopedics must undergo substantial improvements in complication assessment and reporting (particularly in comparison with trials in other medical specialties such as rheumatology), and that a universal classification system for complications should be developed as an outcome tool. The results of this present study clearly indicate that this recommendation is equally relevant to studies of total ankle-arthroplasty.…”

Section: Discussionmentioning

confidence: 99%

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty

et al. 2015

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Section: Discussionmentioning

confidence: 99%

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty

et al. 2015

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“…The reporting of adverse events in former papers on total joint replacement mainly focuses on major surgical adverse events like wound infection, fracture or loosening of the implant[5-10]. Therefore medical adverse events are likely to be underreported in these investigations [11]. In an evidence report on total knee arthroplasty [12] a more complete list of adverse medical as well as surgical events is published.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2010

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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.

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“…Complications are not only important for the evaluation of surgical safety, progress and improvement of treatment, but also to compare different implants for the same fracture pattern, and, last but not least, for the high-risk-patient identification [98]. Especially radiologically assessed complications such as malreduction, fracture-displacement, malunion or humeral head necrosis are not defined in satisfying ways.…”

Section: Discussionmentioning

confidence: 99%

Complication rates and outcomes stratified by treatment modalities in proximal humeral fractures: a systematic literature review from 1970–2009

et al. 2013

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BackgroundThe optimal treatment of complex, displaced proximal humeral fractures is controversial. A systematic literature review of the time period from 1970 to 2009 was conducted. The purpose was to evaluate the clinical success and complications of the available treatment modalities to determine specific treatment recommendations for the different fracture patterns.MethodsThe databases (PubMed/EMBASE) were searched for the time period (01/1970–09/2009). Study quality, treatment modalities, classification, outcome scores and complications of 200 publications including 9377 patients were analyzed. Interventions were compared by analysis of variance with subsequent Tukey’s-test. Complication rates among methods were compared by using Pearson’s-chi-square-test and pairwise comparisons using Fisher’s-two-tailed-exact-test.ResultsHemiarthroplasty, angle-stable plate and non-operative treatment were used for 63% of the follow-up-patients. For 3- and 4-part fractures, patients with hemiarthroplasty [3-Part: 56.4 (lower/upper 95% confidence interval (CI): 43.3-68.7); 4-Part: 49.4 (CI: 42.2-56.7)] received a lower score than different surgical head-preserving methods such as ORIF [3-Part: 82.4 (CI: 76.6-86.9); 4-Part: 83.0 (CI:78.7-86.6)], intramedullary nailing [3-Part: 79.1 (CI:74.0-83.4)] or angle-stable plates [4-Part: 66.4 (CI: 59.7-72.4)].The overall complication rate was 56%. The most common complications were fracture-displacement, malunion, humeral head necrosis and malreduction. The highest complication rates were documented for conventional plate and hemiarthroplasty and for AO-C, AO-A, for 3- and 4-part fractures. Only 25% of the data were reported with detailed classification results and the corresponding outcome scores.DiscussionDespite the large amount of patients included, it is difficult to determine adequate recommendations for the treatment of proximal humeral fractures because a relevant lack of follow-up data impaired subsequent analysis. For displaced 3- and 4-part fractures head-preserving therapy received better outcome scores than hemiarthroplasty. However, a higher number of complications occurred in more complex fractures and when hemiarthroplasty or conventional plate osteosynthesis was performed. Thus, when informing the patient for consent, both the clinical results and the possibly expected complications with a chosen treatment modality should be addressed.

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Complication Reporting in Orthopaedic Trials

Cited by 60 publications

References 23 publications

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty

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

Complication rates and outcomes stratified by treatment modalities in proximal humeral fractures: a systematic literature review from 1970–2009

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