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Objectives: Open tibia fractures are associated with substantial morbidity and impact on quality of life. Despite increasing incidence in low-resource settings, most open tibia fracture research comes from high-resource settings. This study aimed to assess the impact of socioeconomic status on treatment modality and evaluate predictors of health-related quality of life following open tibia fractures in Ghana., Design: A single-center prospective observational study was conducted in Kumasi, Ghana, from May 2020 to April 2022. Adults with open tibial shaft fractures presenting within 2 weeks of injury were eligible. Demographics, comorbidities, socioeconomic factors, and hospital course were collected at enrollment. Follow-up was scheduled at 8, 12, 26, and 52 weeks. A telephone survey assessing reasons for loss to follow-up was initiated on enrollment completion., Results: A total of 180 patients were enrolled. Most patients were employed before injury (79.9%), had government insurance (67.2%), and were from rural areas (59.4%). Fracture classification was primarily Gustilo-Anderson type 3A (49.1%). No relationship between socioeconomic predictors and treatment modality was identified. The largest barriers to follow-up were preference for bonesetter treatment (63.1%), treatment cost (48.8%), and travel cost (29.8%). Of the lost to follow-up patients contacted, 67 (79.8%) reported receiving traditional bonesetter care. Reasons for seeking traditional bonesetter care included ease of access (83.6%), lower cost (77.6%), and familial influence (50.7%)., Conclusion: No association was identified between socioeconomic predictors and choice of treatment. Bonesetter treatment plays a substantial role in the care of open tibia fractures in Ghana, largely because of ease of access and lower cost., Competing Interests: The authors have no conflict of interest to report., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Orthopaedic trauma remains a leading cause of patient morbidity, mortality, and global health care burden. Although significant advances have been made in the diagnosis, treatment, and rehabilitation of these injuries, complications such as malunion, nonunion, infection, disuse muscle atrophy and osteopenia, and incomplete return to baseline function still occur. The significant inherent clinical variability in fracture care such as differing patient demographics, injury patterns, and treatment protocols make standardized and replicable study, especially of cellular and molecular based mechanisms, nearly impossible. Hence, the scientists dedicated to improving therapy and treatments for patients with orthopaedic trauma rely on preclinical models. Preclinical models have proven to be invaluable in understanding the timing between implant insertion and bacterial inoculation on the bioburden of infection. Posttraumatic arthritis (PTOA) can take years to develop clinically, but with a porcine pilon fracture model, posttraumatic arthritis can be reliably induced, so different surgical and therapeutic strategies can be tested in prevention. Conversely, the racehorse presents a well-accepted model of naturally occurring PTOA. With preclinical polytrauma models focusing on chest injury, abdominal injury, multiple fractures, and/or head injury, one can study how various injury patterns affect fracture healing can be systemically studied. Finally, these preclinical models serve as a translational bridge to for clinical application in human patients. With selection of the right preclinical model, studies can build a platform to decrease the risk of emerging technologies and provide foundational support for therapeutic clinical trials. In summary, orthopaedic trauma preclinical models allow scientists to simplify a complex clinical challenge, to understand the basic pathways starting with lower vertebrate models. Then, R&D efforts progress to higher vertebrate models to build in more complexity for translation of findings to the clinical practice., Competing Interests: The authors report no conflict of interest., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objectives: To estimate the indirect economic impact of tibial fractures and their associated adverse events (AEs) in Tanzania., Design: A secondary analysis of the pilot Gentamicin Open (pGO)-Tibia randomized control trial estimating the indirect economic impact of suffering an AE, defined as a fracture-related infection (FRI) and/or nonunion, after an open tibial fracture in Tanzania., Setting: The pGO-Tibia trial was conducted from November 2019 to August 2021 at the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania., Patients/participants: One hundred adults with open tibial shaft fractures participated in this study., Intervention: Work hours were compared between AE groups. Cost data were analyzed using a weighted-average hourly wage and converted into purchasing power parity-adjusted USD., Main Outcome Measurements: Indirect economic impact was analyzed from the perspective of return to work (RTW), lost productivity, and other indirect economic and household costs. RTW was analyzed using a survival analysis., Results: Half of patients returned to work at 1-year follow-up, with those experiencing an AE having a significantly lower rate of RTW. Lost productivity was nearly double for those experiencing an AE. There was a significant difference in the mean outside health care costs between groups. The total mean indirect cost was $2385 with an AE, representing 92% of mean annual income and an increase of $1195 compared with no AE. There were significantly more patients with an AE who endorsed difficulty affording household expenses postinjury and who borrowed money to pay for their medical expenses., Conclusions: This study identified serious economic burden after tibial fractures, with significant differences in total indirect cost between those with and without an AE., Level of Evidence: II., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Effective nonunion and bone defect management requires consideration of multiple potential contributing factors including biomechanics, biology, metabolic, and patient factors. This article reviews these factors as well as several potential nonunion or bone defect treatments including bone grafts, bone graft substitutes, the induced membrane technique, and distraction osteogenesis. A summary of these concepts and guidelines for an overall approach to management are also provided., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Randomized controlled trials are the gold standard to establishing causal relationships in clinical research. However, these studies are expensive and time consuming to conduct. This article aims to provide orthopaedic surgeons and clinical researchers with methodology to optimize inference and minimize bias in observational studies that are often much more feasible to undertake. To mitigate the risk of bias arising from their nonexperimental design, researchers must first understand the ways in which measured covariates can influence treatment, outcomes, and missingness of follow-up data. With knowledge of these relationships, researchers can then build causal diagrams to best understand how to control sources of bias. Some common techniques for controlling for bias include matching, regression, stratification, and propensity score analysis. Selection bias may result from loss to follow-up and missing data. Strategies such as multiple imputation and time-to-event analysis can be useful for handling missingness. For longitudinal data, repeated measures allow observational studies to best summarize the impact of the intervention over time. Clinical researchers familiar with fundamental concepts of causal inference and techniques reviewed in this article will have the power to improve the quality of inferences made from clinical research in orthopaedic trauma surgery., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Background: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture., Methods: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection., Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes., Conclusion: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting., Competing Interests: The authors have no conflicts of interest to disclose, (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

International observerships are one of many efforts aimed at addressing disparities in orthopaedic trauma care globally. However, their impact on visiting surgeons and their home countries, as well as the challenges faced by participating surgeons, are not well-documented., Methods: A survey was distributed to overseas surgeons who participated in an orthopaedic trauma observership from 2009 to 2020. Surgeons were identified through North American institutions previously recognized by the authors as having hosted international observerships. Information gathered included participant demographics, details of and perceived impact of the observership, and barriers faced before, during, and after the program. Responses from 148 international surgeons (ISs) from 49 countries were analyzed., Results: Sixty percent of observerships were at academic programs, 57% lasted 1-3 months, and 60% were self-funded. Participants identified cost and housing as primary barriers. After completing their observership, lack of funding, equipment and support staff, and excessive workload prevented participants from implementing changes at their clinical practice. Most observers believed that they gained relevant clinical (89%) and surgical knowledge (67%) and developed a professional network of North American hosts (63%). The most common suggested changes to the observership were greater hands-on experience in the operating room and structured goal setting relevant to the visiting surgeon., Conclusions: Visiting surgeons find North American orthopaedic trauma observerships helpful in improving their surgical and clinical skills. However, financial constraints and resource limitations at their clinical practice and limited operative experience during the observership present barriers to maximizing this clinical experience. To enhance the relevance of clinical observerships for ISs and impact global orthopaedic trauma care, the unique needs and challenges facing ISs must be addressed., Level of Evidence: IV-Cross-Sectional Study., Competing Interests: The authors report no conflict of interest., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objectives: Open tibia fractures pose a clinical and economic burden that is disproportionately borne by low-income countries. A randomized trial conducted by our group showed no difference in infection and nonunion comparing 2 treatments: external fixation (EF) and intramedullary nailing (IMN). Secondary outcomes favored IMN. In the absence of clear clinical superiority, we sought to compare costs between EF and IMN., Design: Secondary cost analysis., Setting: Single institution in Tanzania., Patients/participants: Adult patients with acute diaphyseal open tibia fractures who participated in a previous randomized controlled trial., Intervention: SIGN IMN versus monoplanar EF., Main Outcome Measurements: Direct costs of initial surgery and hospitalization and subsequent reoperation: implant, instrumentation, medications, disposable supplies, and personnel costs.Indirect costs from lost productivity of patient and caregiver.Societal (total) costs: sum of direct and indirect costs.All costs were reported in 2018 USD., Results: Two hundred eighteen patients were included (110 IMN, 108 EF). From a payer perspective, costs were $365.83 (95% CI: $332.75-405.76) for IMN compared with $331.25 ($301.01-363.14) for EF, whereas from a societal perspective, costs were $2664.59 ($1711.22-3955.25) for IMN and $2560.81 ($1700.54-3715.09) for EF. The largest drivers of cost were reoperation and lost productivity. Accounting for uncertainty in multiple variables, probabilistic sensitivity analysis demonstrated that EF was less costly than IMN from the societal perspective in only 55% of simulations., Conclusions: Intramedullary nail fixation compared with external fixation of open tibia fractures in a resource-constrained setting is not associated with increased cost from a societal perspective., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objectives: The incidence of hip fracture is high and increasing globally due to an aging population. Morbidity and mortality from these injuries are high at baseline and worse without prompt surgical treatment to facilitate early mobilization. Due to resource constraints, surgeons in low-income countries often must adapt available materials to meet these surgical needs. The objective of this study is to assess functional outcomes after surgical fixation of intertrochanteric femur fractures with the Surgical Implant Generation Network (SIGN) intramedullary nail augmented by a lateral SIGN plate., Design: Prospective case series., Setting: Juba Teaching Hospital, Tertiary Referral Hospital for South Sudan., Participants: Adult patients with intertrochanteric hip fractures., Intervention: SIGN nail augmented by a lateral plate., Main Outcome Measurements: Primary outcome was hip function as measured by a modified Harris Hip Score (mHHS) at 1-year after surgery. Secondary endpoints were the occurrence of reoperation or infection at 1-year after surgery., Results: Thirty patients were included, 16 (53%) men and 14 (47%) women, with a mean age of 62 years. Fractures were classified as AO/OTA Type 31A1 in 12 (40%) patients, 31A2 in 15 (50%) patients, and 31A3 in 3 (10%) patients. Mean mHHS at 1-year was 75.10 ± 21.2 with 76% categorized as excellent or good scores. There was 1 (3%) infection and 2 (7%) reoperations., Conclusions: The SIGN nail augmented by a lateral plate achieved good or excellent hip function in the majority of patients with intertrochanteric hip fractures. This may be a suitable alternative to conventional implants for hip fracture patients in low-resource settings to allow mobilization., Competing Interests: LZ is president and founder of SIGN Fracture Care International. DS serves as vice president of SIGN Fracture Care International. No other authors have any conflicts of interests to disclose., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

The conception-to-market development of orthopaedic devices occurs across the total product life cycle including device design and preclinical testing, clinical investigations to support marketing applications, and monitoring of device performance after market introduction. This process involves industry, regulatory agencies, health care providers, engineers, scientists, and patients. The Food and Drug Administration (FDA) is responsible for regulating medical devices in the United States, and uses a 3-tier classification system based on the level of control necessary to provide reasonable assurance of safety and effectiveness. Classification directs the required regulatory pathway and premarket submission type. Variations in global regulations, particularly between the United States, European Economic Area (EEA), and the United Kingdom (UK), may impact industry response to orthopaedic device development. Changing device innovation and reimbursement models have led to the consolidation of market share among larger companies. Although larger companies are better able to cope with more rigorous regulatory requirements, this leads to decreased competition and increased upward price pressure. To assist with the complex regulatory processes, the FDA offers pre-submission assistance as an opportunity for early collaboration and discussion about the medical device or device-led combination product submissions. Orthopaedic organizations, such as the Orthopaedic Trauma Association (OTA), may assist in postmarket device surveillance through the coordinated development and maintenance of clinical data registries. Such registries can longitudinally follow patients with a specific orthopaedic pathology or device usage, and monitor outcomes towards improvements in next-generation device development. As technology evolves, the nexus of regulation, industry, and patient outcome monitoring will continue to support safe and effective device innovation., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

To compare clinical and radiographic outcomes following antegrade versus retrograde intramedullary nailing of infraisthmic femoral shaft fractures., Design: Secondary analysis of prospective cohort study., Setting: Tertiary hospital in Tanzania., Participants: Adult patients with infraisthmic diaphyseal femur fractures., Intervention: Antegrade or retrograde SIGN intramedullary nail., Outcomes: Health-related quality of life (HRQOL), radiographic healing, knee range of motion, pain, and alignment (defined as less than or equal to 5 degrees of angular deformity in both coronal and sagittal planes) assessed at 6, 12, 24, and 52 weeks postoperatively., Results: Of 160 included patients, 141 (88.1%) had 1-year follow-up and were included in analyses: 42 (29.8%) antegrade, 99 (70.2%) retrograde. Antegrade-nailed patients had more loss of coronal alignment ( P  = .026), but less knee pain at 6 months ( P  = .017) and increased knee flexion at 6 weeks ( P  = .021). There were no significant differences in reoperations, HRQOL, hip pain, knee extension, radiographic healing, or sagittal alignment., Conclusions: Antegrade nailing of infraisthmic femur fractures had higher incidence of alignment loss, but no detectable differences in HRQOL, pain, radiographic healing, or reoperation. Retrograde nailing was associated with increased knee pain and decreased knee range of motion at early time points, but this dissipated by 1 year. To our knowledge, this is the first study to prospectively compare outcomes over 1 year in patients treated with antegrade versus retrograde SIGN intramedullary nailing of infraisthmic femur fractures.Level of Evidence: III., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objectives: To determine the international reliability and validity of the modified Radiographic Union Scale for Tibial fracture (mRUST) scoring method for open tibial shaft fractures based on ratings of radiographs by separate groups of North American and Tanzanian surgeons., Methods: Seven North American and 9 Tanzanian surgeons viewed 100 pairs of AP and lateral radiographs of open tibial shaft fractures obtained in Dar Es Salaam, Tanzania. The radiographs showed 25 patients' fractures at 4 time points postfracture after treatment with either external fixation or intramedullary nailing. Surgeons evaluated each fracture using the mRUST scoring method and indicated their confidence that the fracture was healed on a scale from 1 to 10. Reliability of mRUST was determined using inter-rater agreement among North American and Tanzanian surgeons. Validity was determined via analysis of correlation between mRUST scores and EQ-5D-3L index scores at each time point postfracture., Results: mRUST scores demonstrated strong reliability overall (ICC = 0.64) as well as within each group of North American (ICC = 0.72) and Tanzanian (ICC = 0.69) surgeons. Reliability was stronger for external fixation than for intramedullary nailing cases. mRUST scores were significantly correlated with overall healing confidence at all time points and with quality of life at 6 months and 1 year postfracture. mRUST scores also correlated significantly with patients' quality of life scores (EQ-5D index) at 6 months and 1 year postfracture., Conclusion: North American and Tanzanian surgeons exhibited strong agreement in rating open tibial shaft fractures. Using mRUST scores is a valid means of assessing radiographic healing of tibial fractures in austere environments like Tanzania., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Background: While the global burden of musculoskeletal injury is increasingly recognized, few epidemiologic studies have specifically recorded its incidence or prevalence, particularly in low- and middle-income countries. Understanding the burden of musculoskeletal injury relative to other health conditions is critical to effective allocation of resources to mitigate the disability that results from trauma. The current study aims to systematically review the existing primary literature on the incidence and prevalence of pelvic and appendicular fractures, a major component of musculoskeletal injury, in low- and lower-middle income countries (LMICs)., Methods: This study conforms to the systematic review and traditional meta-analysis guidelines outlined in the PRISMA-P statement. Incidence rates were calculated as the occurrence of new fracture cases per 100,000 person-years, and prevalence as total fracture cases per population sample, reported as percentages., Results: The literature search yielded 3497 total citations. There were 21 full-text articles, representing 14 different countries, selected for data extraction. Included studies reported a wide range of incidence and prevalence rates, with an overall mean fracture incidence ranging from 779 (95% CI: 483.0-1188.7) to 1574 (95% CI: 1285.1-1915.1) per 100,000 person-years., Conclusion: Better understanding the unmet burden of musculoskeletal injury in LMICs is critical to effectively allocating resources and advocating for underserved populations. To address existing gaps and heterogeneity within the literature, future research should incorporate population-based sampling with broader geographic representation in LMICs to more accurately capture the burden of disease., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objective: Predict loss to follow-up in prospective clinical investigations of lower extremity fracture surgery., Design: Secondary analysis of 2 prospective clinical trials., Setting: National public orthopaedic and neurologic trauma tertiary referral hospital in Dar es Salaam, Tanzania, a low-income country in sub-Saharan Africa., Patients/participants: Three hundred twenty-nine femoral shaft and 240 open tibial shaft fracture patients prospectively enrolled in prospective controlled trials of surgical fracture management by external fixation, plating, or intramedullary nailing between June 2015 and March 2017., Intervention: Telephone contact for failure to attend scheduled 1-year clinic visit., Main Outcome Measurements: Ascertainment of primary trial outcome at 1-year from surgery; post-hoc telephone questionnaire for reasons patient did not attend the 1-year clinic visit., Results: One hundred twenty-seven femur fracture (39%) and 68 open tibia fracture (28%) patients did not attend the 1-year clinic visit. Telephone contact significantly improved ascertainment of the primary study outcome by 20% between 6-month and 1-year clinic visits to 82% and 92% respectively at study completion. Multivariable analysis associated unemployment (OR = 2.5 [1.7-3.9], P  < .001), treatment with an external fixator (OR = 1.7 [1.0-2.8], P  = .033), and each additional 20 km between residence and clinic (OR = 1.03 [1.00-1.06], P  = .047] with clinic nonattendance. One hundred eight (55%) nonattending patients completed the telephone questionnaire, reporting travel distance to the hospital (49%), and travel costs to the hospital (46%) as the most prevalent reasons for nonattendance. Sixty-five percent of patients with open tibia fractures cited relocation after surgery as a contributing factor., Conclusions: Relocation during recovery, travel distance, travel cost, unemployment, and use of an external fixator are associated with loss to clinical follow-up in prospective investigations of femur and open tibia fracture surgery in this population. Telephone contact is an effective means to assess outcome., Competing Interests: DWS received grants from the Orthopaedic Research and Education Foundation (OREF) and Orthopaedic Trauma Association (OTA) exclusively to support the Tanzania Femur Trial; and grants from Wyss Medical Foundation and Doris Duke Charitable Foundation exclusively to support the Tanzania Open Tibia Study. SM is a board or committee member of the OTA. JTP, PDA, JHJ, ENE, BTH, certify that they have no financial conflict of interest (e.g., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) in connection with this article. The authors have no conflicts of interest to disclose., (Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Background: An increasing number of traumatic injuries in low- and low-middle-income countries (LICs/LMICs) have coexisting injuries requiring soft-tissue coverage (flaps). Yet, there is a lack of subspecialty care and flap training in Latin America. This study assesses the effectiveness of a surgical skills training course in improving rotational and free flap knowledge and identifies barriers to performing these types of flaps., Methods: Participants attending a surgical skills training course in Guadalajara, Mexico completed a pre/postcourse flaps knowledge survey consisting of 15 questions from the plastic surgery in-training examination and also completed a 7-point Likert survey regarding perceived barriers to performing flaps at their institution., Results: Of the course participants, 17 (44.7%) completed the precourse knowledge survey, 24 (63.2%) completed the postcourse survey, and 37 (97.4%) completed the barriers survey. Scores improved from pre- to postcourse knowledge surveys (39.6% to 53.6%, P  = .005). Plastic surgery subsection scores also improved (39.0% to 60.4%, P  = .003). Twenty-five percent of attendees received prior flap training and had plastic surgeons available to perform flaps. Few participants (38.9%) reported flap procedures being commonly completed at their hospitals. Participants stating that flaps were uncommon in their hospital reported more institutional barriers and less access to dermatomes. These participants also reported lack of operating room and surgical personnel availability., Conclusion: A surgical skills training course may be useful in improving knowledge of soft-tissue coverage procedures. There are also modifiable physician and institutional barriers that can improve the ability to perform rotational and free flaps as identified by the course participants., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2019 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)

Objective: In 21 patients, our objective was the endoscopic removal of common bile duct stones by sphincter dilation with the application of sublingual nitroglycerin., Methods: Nitroglycerin 0.3-0.6 mg was needed for proper dilation of the orifice and for successful cannulation of the Dormia basket into the bile duct. Cannulation of the Dormia basket was simplified by placing the guidewire in the common bile duct beforehand. Because of possible stone impaction, a mechanical lithotriptor was applied smoothly in two patients., Results: Complete stone removal was successful in 18 of the 21 (86%) patients. One patient who developed a mild form of acute pancreatitis recovered in a few days by conservative management with drip infusion of protease inhibitor. Blood pressure dropped transiently in a patient receiving nitroglycerin, but the general condition of the patient was stable., Conclusions: This procedure was found to be safe, easy, and effective in extracting common bile duct stones.