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Objective To compare assisted vaginal delivery by forceps with delivery by vacuum extractor, where a new vacuum extractor policy was employed which dictated the cup to be used in specific situations. Design Multicentre randomised controlled trial. Setting Four district general hospitals in the West Midlands. Subjects Six hundred‐seven women requiring assisted vaginal delivery, of whom 296 were allocated to vacuum extractor delivery and 311 to forceps. Main outcome measures Delivery success rate, maternal perineal and vaginal injuries, maternal anaesthetic requirements, neonatal scalp and facial injuries. Results Of the vacuum extractor group, 85% were delivered by the allocated instrument compared to 90% in the forceps group (odds ratio (OR) 0.64; 95% confidence intervals (CI) 0.4–1.04). However, more women in the vacuum extractor group were delivered vaginally (98%) than in the forceps group (96%). There were significantly fewer women with anal sphincter damage or upper vaginal extensions in the vacuum extractor group (11%vs 17%, OR 0.6; 95% CI, 0.38–0.97). There were significantly fewer women in the vacuum extractor group requiring epidural or spinal anaesthetics (25.4%vs 32.7%, OR 0.69; 95% CI 0.49–0.99) or general anaesthetics (1%vs 4%, OR 0.17; 95% CI 0.04–0.76). Although there were significantly more babies in the vacuum extractor group with cephalhaematomata (9%vs 3%, OR 3.3; 95% CI 1.4–7.4) there were fewer babies in the vacuum extractor group with other facial injuries. There were three babies in the forceps group with unexplained neonatal convulsions. Conclusions Assisted vaginal delivery using the new vacuum extractor policy is associated with significantly less maternal trauma than with forceps. Further studies are required to assess neonatal morbidity adequately.

Background Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings. Methods We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures. Discussion The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries. Trial registration ClinicalTrials.gov, Registration # NCT03559400; Registered June 18, 2018.

Purpose of Review To discuss the automated risk calculators that have been developed and evaluated in orthopedic surgery. Recent Findings Identifying predictors of adverse outcomes following orthopedic surgery is vital in the decision-making process for surgeons and patients. Recently, automated risk calculators have been developed to quantify patient-specific preoperative risk associated with certain orthopedic procedures. Automated risk calculators may provide the orthopedic surgeon with a valuable tool for clinical decision-making, informed consent, and the shared decision-making process with the patient. Understanding how an automated risk calculator was developed is arguably as important as the performance of the calculator. Additionally, conveying and interpreting the results of these risk calculators with the patient and its influence on surgical decision-making are paramount. Summary The most abundant research on automated risk calculators has been conducted in the spine, total hip and knee arthroplasty, and trauma literature. Currently, many risk calculators show promise, but much research is still needed to improve them. We recommend they be used only as adjuncts to clinical decision-making. Understanding how a calculator was developed, and accurate communication of results to the patient, is paramount.

Introduction: Low- and middle-income countries (LMICs) experience a large volume of orthopaedic trauma, but limited research exists to evaluate effective treatments using locally available means. Academic partners can help design and implement research studies through collaborative efforts with local investigators. We will describe the study design and lessons learned from a randomized controlled trial in Tanzania comparing outcomes of 2 operative treatments for open tibia fractures. Study Design: The Institute for Global Orthopaedics and Traumatology at the University of California, San Francisco, and the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, partnered to design a prospective, randomized controlled trial. Adult patients with open tibia fractures were randomized to receive either intramedullary nailing or external fixation as definitive fixation. Our primary outcome was the rate of reoperation, and secondary outcomes included EQ-5D, pain, function, radiographic union, and return to work. Results: We enrolled 40 patients in a pilot study that informed improvements in the study design and standard operating procedures. These modifications included development of a specific outline of the technical standards for each surgical intervention and held training workshops to disseminate this knowledge among operative surgeons. This resulted in the successful enrollment and standardized treatment of our target sample of 240 patients. Discussion: There are several challenges in conducting high-quality, international research. Keys for success include maintaining a strong relationship between partners, having local research coordinators, simplifying data collection and storage, and incentivizing patients to attend follow-up visits.