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STUDY QUESTIONCan risks associated with novelties in assisted reproduction technologies (ARTs) be assessed in a systematic and structured way?SUMMARY ANSWERAn ART-specific risk assessment tool has been developed to assess the risks associated with the development of novelties in ART (EuroGTP II-ART).WHAT IS KNOWN ALREADYHow to implement new technologies in ART is well-described in the literature. The successive steps should include testing in animal models, executing pre-clinical studies using supernumerary gametes or embryos, prospective clinical trials and finally, short- and long-term follow-up studies on the health of the offspring. A framework categorizing treatments from experimental through innovative to established according to the extent of the studies conducted has been devised. However, a systematic and standardized methodology to facilitate risk evaluation before innovations are performed in a clinical setting is lacking.STUDY DESIGN, SIZE, DURATIONThe EuroGTP II-ART risk assessment tool was developed on the basis of a generic risk assessment algorithm developed for tissue and cell therapies and products (TCTPs) in the context of the project ‘Good Practices for demonstrating safety and quality through recipient follow-up European Good Tissue and cells Practices II (EuroGTP II)’. For this purpose, a series of four meetings was held in which eight ART experts participated. In addition, several tests and simulations were undertaken to fine-tune the final tool.PARTICIPANTS/MATERIALS, SETTING, METHODSThe three steps comprising the EuroGTP II methodology were evaluated against its usefulness and applicability in ART. Ways to improve and adapt the methodology into ART risk assessment were agreed and implemented.MAIN RESULTS AND THE ROLE OF CHANCEAssessment of the novelty (Step 1), consisting of seven questions, is the same as for other TCTPs. Practical examples were included for better understanding. Identification of potential risks and consequences (Step 2), consisting of a series of risks and risk consequences to consider during risk assessment, was adapted from the generic methodology, adding more potential risks for processes involving gonadic tissues. The algorithm to score risks was also adapted, giving a specific range of highest possible risk scores. A list of strategies for risk reduction and definition of extended studies required to ensure effectiveness and safety (Step 3) was also produced by the ART experts, based on generic EuroGTP II methodology. Several explanations and examples were provided for each of the steps for better understanding within this field.LIMITATIONS, REASONS FOR CAUTIONA multidisciplinary team is needed to perform risk assessment, to interpret results and to determine risk mitigation strategies and/or next steps required to ensure the safety in the clinical use of novelties.WIDER IMPLICATIONS OF THE FINDINGSThis is a dynamic tool whose value goes beyond assessment of risk before implementing a novel ART in clinical practice, to re-evaluate risks based on information collected during the process.STUDY FUNDING / COMPETING INTEREST(S)This study was called EUROGTP II and was funded by the European Commission (Grant agreement number 709567). The authors declare no competing interests concerning the results of this study.

Estudo retrospectivo de 19 casos de fratura-luxação de Lisfranc tratados cirurgicamente no período de 1995 a 2003. O tempo de acompanhamento foi de 35 meses (variando de 4 a 97 meses). O tratamento cirúrgico foi realizado no dia do trauma em 14 casos, com média de demora de 4,78 horas. Ocorreram 5 lesões expostas (36,32%) e 5 pacientes foram vítimas de politraumatismo. O mecanismo de lesão mais freqüente foi o acidente motociclístico, seguido da queda de animais e de altura. Utilizou-se a avaliação funcional proposta pela AOFAS (The American Orthopaedic Foot And Ankle Society), que apresentou média de 77,53 (variou de 44 a 100). Houve relação entre a qualidade da redução obtida e o resultado do tratamento (p = 0,0449) e entre o fato do pacientes ser vítima de politraumatismo e um resultado inferior do escore AOFAS (p= 0.0143). Houve como complicação a presença de Osteoartrose em 8 casos (42,10%), confirmando-a como a principal complicação radiográfica destas lesões. Sua ocorrência foi analisada comparando-se com a qualidade da redução e com os diferentes tipos de lesão (exposta,lesão ligamentar ou fratura, se lesão isolada ou politraumatismo) não encontrando relação com significância estatística (p < 0,005). This was a retrospective study of 19 cases of Lisfranc fracture-dislocation surgically treated during the period of 1995 - 2003. The follow-up period was 35 months (range: 4 - 97 months). Surgical treatment was provided on the day of the injury in 14 cases, taking an average of 4.78 hours. There were 5 open injuries (36.32%) and 5 patients experienced multiple injuries. The most frequent mechanisms of injury were motorcycle accidents, followed by falls from animals, and high falls. The functional evaluation proposed by AOFAS (The American Orthopaedic Foot and Ankle Society) was employed, which reported an average of 77.53 (ranging from 44 to 100). A correlation was found between the quality of the reduction achieved and treatment outcome (p = 0.0449), and between multiple traumas and poorer AOFAS score results (p = 0.0143). Complications such as osteoarthritis occurred in 8 cases (42.10%), confirming this as the main radiographic complication of these injuries. Its incidence was analyzed comparing the quality of the reduction to the different types of injury (open or closed, ligament injury or fracture, isolated injury or multiple injuries) not reporting any statistically significant correlation (p