Background

The JOURNEY™ II Cruciate-Retaining Total Knee System (JIICR) and the JOURNEY™ II Bi-Cruciate Stabilized Total Knee System (JIIBCS) (both, Smith & Nephew, Memphis, TN, USA) are used for the treatment of end-stage degenerative knee arthritis. Belonging to the JOURNEY family of knee implants, the relatively new devices are designed to provide guided motion. Studies suggest that long-term outcomes of robotic-assisted navigation in total knee arthroplasty (TKA) are superior to the classical approach. This is the first report describing early postoperative outcomes of the NAVIO® robotic-assisted surgical navigation using the JOURNEY™ II family of knee implants.

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.

Purpose: The choice of irrigating fluid and delivery pressure remains controversial. Identifying surgeons’ preferences in techniques and the rationale for their choices may aid in focusing educational activities to the orthopaedic community as well as planning future clinical trials. Our objective was to clarify current opinion with regard to the irrigation of open fracture wounds.

Method: We mailed and delivered a cross-sectional survey using a sample-to-redundancy strategy to members of the Canadian Orthopaedic Association and attendees of an international fracture course (AO, Davos, Switzerland) to examine surgeons’ preferences in the initial management of open fracture wounds.

Results: Of the 1,764 surgeons who received the questionnaire, 984 (55.8%) responded. In the management of open wounds, most surgeons surveyed, 676 (70.5%), favoured normal saline alone, however 16.8% used Bacitracin. Many surgeons, 695 (71%) used low pressures when delivering the irrigating solution to the wound, however variation exists in what constituted high versus low pressure lavage. Surgeons supported the need for a clinical trial evaluating outcomes following both the use of different irrigating solutions as well as irrigating pressures [803 (84.8%) and 730 (77.6%) respectively].

Conclusion: The majority of surgeons favour both normal saline and low pressure lavage for the initial management of open fracture wounds.

Objectives: An evidence-based trauma database that rated the level-of-evidence for the majority of orthopedic trauma literature would be useful to orthopedic trauma surgeons and researchers. Currently, the development of a database using evidence ratings for such a large body of literature is a time-consuming and expensive endeavor. However, if an accurate rating could be obtained from an abstract without reading the full text, such an endeavor would be feasible. Thus, the purpose of this study is to determine if a reviewer can successfully ascertain the level-of-evidence from the article’s abstract without reading the full text article.

Methods: We compared the level-of-evidence rating obtained from reading an article’s full text with the rating obtained from reading the abstract alone. We reviewed 162 clinical articles published from January 2000 through April 2004 in five orthopedic trauma journals. To establish a full text rating, two reviewers independently rated the full text of each article for study type (therapeutic, prognostic or diagnostic) and level-of-evidence (I through V). The ratings from the two reviewers were compared and disagreements were reconciled through discussion to form a final full text rating. A third reviewer rated the abstracts of each article without access to the full text or full text rating.

Results: Of the 162 articles, 118 (73%) were therapeutic, 40 (25%) were prognostic and 4 (3%) were diagnostic. Most studies represented level IV evidence (65%), with only 15% representing the highest level-of-evidence, level I. Kappa values for agreement between the two reviewers rating the full text were 0.81 for study type and 0.79 for level-of-evidence, and the kappa values for agreement between the final full text rating and the abstract rating were 0.68 for study type and 0.75 for level-of-evidence, respectively. Thirteen of the discordant abstracts (8% of the entire set) lacked sufficient or correct evidence compared with the full text to render an accurate rating.

Conclusion: Accurate study type and level-of-evidence rating in trauma articles can be obtained in most orthopedic trauma articles from reading an article’s abstract alone. Thus, developing an evidence-based trauma database that uses abstracts to rate the level-of-evidence of the orthopedic trauma literature appears feasible and appropriate.

This research was supported by a grant from the AO Foundation, Clinical Investigation and Documentation, Clavadelerstrasse, 7270 Davos Platz, Switzerland

Little is known about the psychological morbidity associated with orthopaedic trauma. Our study aimed to determine the extent of psychological symptoms and whether patient psychological symptoms were predictive of outcomes following orthopaedic trauma. Overall, trauma patients experienced higher intensity of psychological symptoms than population norms. Psychological symptoms, patient age, and ongoing litigation predicted functional outcomes. Patients may benefit from early interventions by social workers and psychologists to process their psychological states post injury.

Little is known about the psychological morbidity associated with orthopaedic trauma.

Our study aimed to determine the extent of psychological symptoms and whether patient psychological symptoms were predictive of outcomes following orthopaedic trauma.

All patients attending ten orthopaedic fracture clinics at three University-affiliated Hospitals were approached for study eligibility. All consenting patients would be requested to complete a baseline assessment form, a 90-item symptom checklist-90R (SCL-90R), and the Short-Form–36. The SCL-90R constitutes nine dimensions (Somatization, Obsessive-compulsive, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, Psychoticism) and three global indices (Global severity index, Positive symptom distress index, positive symptom total). We conducted regression analyses to determine predictors of quality of life among study patients.

Of two hundred and fifteen patients, 59% were male at a mean age of 44.5 years. Over half of patients had lower extremity fractures. Trauma patients experienced greater psychological symptoms than population norms. Overall, trauma patients experienced higher intensity of psychological symptoms than population norms. Patient functional outcomes were predicted by patient age, ongoing litigation, and Positive Symptom Distress. This model predicted 21% of the variance in patient function. Patient somatization was an important psychological symptom resulting in increasing intensity of symptoms. Smoking, alcohol, open fracture, surgeons’ perception of technical outcome, level of education, and time since injury were not predictive in this model.

Psychological symptoms, patient age, and ongoing litigation predicted functional outcomes. Patients may benefit from early interventions by social workers and psychologists to process their psychological states post injury.

Funding: This study was funded in part by research grants from AO North America and Regional Medical Associates, McMaster University. Dr. Bhandari was funded, in part, by a 2004 Detweiler Fellowship, Royal Colleges of Physicians and Surgeons of Canada. Dr. Busse is funded by a Canadian Institutes of Health Research Fellowship Award.

Introduction: Little is known about the psychological morbidity associated with orthopaedic trauma.

Purpose: Our study aimed to determine the extent of psychological symptoms and whether patient psychological symptoms were predictive of outcomes following orthopaedic trauma.

Methods: All patients attending 10 orthopaedic fracture clinics at 3 University-affiliated Hospitals were approached for study eligibility. All consenting patients would be requested to complete a baseline assessment form, a 90-item symptom checklist-90R (SCL-90R), and the Short-Form–36. The SCL-90R constitutes 9 dimensions (Somatization, Obsessive-compulsive, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, Psychoticism) and three global indices (Global severity index, Positive symptom distress index, positive symptom total). We conducted regression analyses to determine predictors of quality of life among study patients.

Results: Of 215 patients, 59% were male at a mean age of 44.5 years. Over half of patients had lower extremity fractures. Trauma patients experienced greater psychological symptoms than population norms. Overall, trauma patients experienced higher intensity of psychological symptoms than population norms. Patient functional outcomes were predicted by patient age, ongoing litigation, and Positive Symptom Distress. This model predicted 21% of the variance in patient function. Patient somatization was an important psychological symptom resulting in increasing intensity of symptoms. Smoking, alcohol, open fracture, surgeons’ perception of technical outcome, level of education, and time since injury were not predictive in this model.

Conclusions: Psychological symptoms, patient age, and ongoing litigation predicted functional outcomes. Patients may benefit from early interventions by social workers and psychologists to process their psychological states post injury.

Bacterial resistance in joint replacement surgery is an emerging problem. A review of the bacteriology from infected revisions performed at Wrightington over the past 5 years has shown that the most common organism is coagulase negative staphylococcus (59%), followed by staphylococcus aureus (17%).

The sensitivity profiles are shown below.

Gentamicin is the most commonly pre formulated antibiotic added to acrylic bone cement. The above data clearly demonstrates that for 32% of infected cases gentamicin alone is inadequate prophylaxis. As a consequence of this the use of additional antibiotics for resistant cases is becoming commonplace.

The aim of this study was to investigate the mechanical properties of additional antibiotics in acrylic bone cement.

The 7 antibiotics listed above were selected on the basis of sensitivity to organisms isolated at revision for deep infection. Each was added at a loading of 1g active to CMW1 RO (plain) and CMW1 G (gentamicin). The antibiotics were mixed with the polymer by hand. The cement was then mixed as per manufacturer’s instructions.

Dough and setting times were noted. Standard samples were produced using ISO approved moulds. Each antibiotic/cement combination was tested for compression strength, impact strength and flexural strength.

All antibiotic/cement combinations performed as well as the control mix when tested for compression and impact strength. The flexural strength results for fusidic acid and erythromycin when added to acrylic cement were comparable to the control mix. Flucloxacillin, clindamycin and teicoplanin did lower the flexural strength to just below acceptable limits. However Vancomycin when added at 1g active reduced the flexural strength of acrylic bone cement significantly.

Although vancomycin may remain one of the last bastions of antibiotic therapy our study suggests that’s its addition to acrylic bone cement significantly weakens its mechanical properties. We would advise caution in its use as this may reduce the chances of long term success when undertaking revision for deep infection.