Objectives

To investigate the differences of open reduction and internal fixation (ORIF) of complex AO Type C distal radius fractures between two different models of a single implant type.

Background: The interpretation of safety data from clinical studies such as complication risks requires clear definition of targeted and documented complication events. In addition a standardized classification of complications is required to allow appropriate comparison of safety data between studies and treatment groups. This presentation highlights a proposal for a standardized management and classification of complication data to initiate and seek consensus among trauma surgeons active in clinical documentation and research.

Methods: Complication events are examined regarding their timing of occurrence as well as their potential causal inter-relationship for any given patient. While independent events are numbered sequentially, directly associated events (e.g. a fracture collapse and implant screw perforation into a joint) receives the same complication number. Complications are described and categorized according to a pre-defined list of anticipated complication types, or as un-anticipated complications. They are further classified as local or general; local complications occur at or directly around the injuries and are further classified as being “Implant/Surgical procedure”, “Bone/Fracture” or “Soft tissue/Wound” events. Information regarding their operative and/or non-operative treatment and their outcome is recorded. Further assessments are made regarding their seriousness, their relation to the implant used. Final classification of complication events is better determined after independent review by a panel of experienced clinicians.

Results: Our classification process was applied successfully to a series of clinical studies at our department. In a study of 185 distal radius fractures treated by LCP, at least one complication occurred in 21 patients, and in seven cases there was a combination of associated events (e.g. one CTS with tendon rupture). Complication risks ranging from 0% to 11.4% were noted depending on which complications and time frames were considered. There was no risk to obtain a LCP implant specific related complication, whereas the risk for a local complication within 6 months after surgery was 6% (95% CI: 3% – 11%).

Conclusions: This management and classification system proved valuable in the documentation and analysis of safety data from clinical studies. It facilitates communication and understanding of definitions between clinicians, as well as allows a prompt, standardised and accurate analysis and reporting of complication events and risks. We encourage other clinical researchers and professionals to participate in the further development and acceptance of a universal classification system for complications in traumatology and orthopaedics.

Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required in the development or improvement of medical procedures and devices. However, neither uniform definitions nor established classifications about the reporting of complications exist. So complication reporting, even in orthopaedic trials is still up to the surgeons perception and understanding. The goal of this systematic review was to check whether essential data are consistently provided by the authors in the assessment of incidence, severity and characteristics of complications related to orthopaedic interventions in randomized controlled trials.

Methods: Five major, peer-reviewed orthopaedic journals were screened for published randomized controlled trials (RCTs) between January 2006 and July 2007. All relevant papers were obtained, anonymized and evaluated by two external reviewers. A checklist consisting of three main parts: definition, evaluation and reporting was developed and applied for the assessment of complication reporting in RCTs. The results were stratified for the main area of the trial.

Results: One hundred and twelve RCTs meeting our inclusion criteria were identified. The majority of RCTs (n = 73) reported on surgical treatment methods, with most of the trials focussing on arthroplasty (38%); surgical fracture treatment and other surgical interventions accounted for 13% each. Although complications were included as trial outcomes in two thirds of the studies, clear definitions of anticipated complications were provided at least partly in only two trials of fracture treatment and six other trials. It remained unclear whether authors considered the specific events “death”, “mal-union”, “impaired function” and “re-operation” as complications; “impaired function” was not considered as a complication in 93% of the trials and “re-operation” events were considered in only 50% of the trials dealing with surgical fracture treatments. In 83% of RCTs, the identity of the person or group assessing the complications was unknown and in a further 8%, this process was implemented by the treating surgeon. This review did not identify any trial involving a Data Safety Review Board for assessment and classification of complications.

Conclusions: Due to the lack of homogeneity among the published trials, improvement in the reporting of complications is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and most importantly, clinical investigators.

We applied the technique of path analysis to investigate the effect of potential prognostic factors, including injury characteristics and treatment choices, on the risk of delayed healing or non-union after operative treatment of tibial shaft fractures.

Data were collected in a prospective observational study of 41 Swiss hospitals over two years, and analysed by regression models and path analysis. Path analysis is a technique to visualize the most important associations between clinical factors and outcome in a ‘causal path diagram’ that summarises the most likely cause and effect relationships.

Factors having a direct relationship with the occurrence of delayed healing or non-union included open fracture (RR 6.7), distal shaft location (RR 2.2), and initial treatment with an external fixator (RR 2.8). There were many other significant inter-relationships within the final diagram. For example, the choice of treatment was related to factors such as fracture aetiology, AO classification, location and skin injury. Fracture classification was not associated with delayed healing and non-union after adjustment for other factors including treatment choice.

The association of hypothesised risk factors, such as soft tissue injury and fracture location, with delayed healing or non-union was confirmed and measured. This study suggested that the use of an external fixator had a direct, negative effect on outcome, and that the use of nails or plates might contribute to delayed healing or non-union by their association with post-operative diastasis. These observations support this first use of path analysis in orthopaedics as a powerful technique to interpret data from an observational study.