Predictors of quality of life, economic impact, and loss to follow-up after open tibial shaft fractures in Ghana.

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.

What factors explain extreme sport participation? A systematic review.

Objective: Extreme sport participation is growing, yet it is still not clear exactly what motivates individuals to participate in sports where accidents can lead to serious injury or death. The purpose of this systematic review was to review and assess current research and identify the factors that explain engagement in extreme sport participation. Methods: A systematic review of PsycInfo, ProQuest, PsychArticles, SportDiscus and Google Scholar was performed according to PRISMA guidelines. Eligibility criteria were defined to identify studies exploring the factors that explain or are associated with taking part in extreme sports. Articles published in English in peer-reviewed journals were retrieved. Results: A total of 35 studies met the eligibility criteria. The sample comprised 17 qualitative studies, 12 quantitative studies, 5 case studies and 1 mixed method study. Findings were categorised into five key themes; "existential and external" (external reasons for participation, e.g., being in nature), "personality" (i.e., stable traits that predicted participation e.g., sensation seeking), "motivation characteristics" (i.e., one's capability and confidence whilst participating, e.g., self-determination theory), "managing risk" (i.e., explanation centred around the desire to take risks e.g., experiential vs. analytical) and "analogies with addiction and withdrawal" (i.e., the behavioural response experienced whilst abstaining from/unable to take part in the sport e.g., craving). Conclusion: There are multiple reasons why individuals participate in extreme sports despite their inherent danger. This review highlights how individuals differing perceptions of risk can impact motivations and therefore the complexity in this area. Potential links between themes and suggestions for future research are also discussed. Systematic Review Registration: https://osf.io/mvk2j.

The economic impact of infection and/or nonunion on long-bone shaft fractures: a systematic review.

Background: Long-bone fractures are a major cause of morbidity worldwide. These injuries are often complicated by infection or nonunion, which significantly affect patient quality of life and economic costs. Although studies have quantified the impact of these fractures, there is not a comprehensive review summarizing their economic and lifestyle costs. Study Objective: This review summarized the impact of long-bone fracture infection and nonunion on health-related quality of life, as measured by utility scores, and both direct and indirect economic costs. Methods: A systematic review was conducted using the following databases: PubMed, EMBASE, Web of Science, and the Cochrane Library. The search included terms related to long-bone fractures, infection, nonunion, cost, and utility. The search yielded 1267 articles, and after deduplication, 1144 were screened, yielding 116 articles for full-text review. Screening was conducted using Covidence and extraction using REDCap. Results: Twenty-two articles met inclusion criteria, with the majority being from the United States and Europe. Most articles were retrospective studies, predominantly regarding the tibia. Fifteen articles contained cost data and 8 contained utility data, with 1 article containing both. Ten cost articles and 1 utility article contained infection data. 8 cost and all utility articles contained nonunion data. Infection ranged from 1.5 to 8.0 times the cost of an uncomplicated fracture. Nonunion ranged from 2.6 to 4.3 times the cost of an uncomplicated fracture. Utility data were variable and ranged from 0.62 to 0.66 for infection and 0.48-0.85 for nonunion. Conclusions: Infection and nonunion after long-bone fractures are associated with large decreases in health-related quality of life and incur substantial costs to both patients and health care systems. The data presented in this review quantify these impacts and may serve useful for future economic analyses. In addition, this study highlights the dearth of high-quality literature on this important topic.

Open fractures: evidence-based best practices.

Open fracture management is a common challenge to orthopaedic trauma surgeons and a burdensome condition to the patient, health care, and entire society. Fracture-related infection (FRI) is the leading morbid complication to avoid during open fracture management because it leads to sepsis, nonunion, limb loss, and overall very poor region-specific and general functional outcomes. This review, based on a symposium presented at the 2022 OTA International Trauma Care Forum, provides a practical and evidence-based summary on key strategies to prevent FRI in open fractures, which can be grouped as optimizing host factors, antimicrobial prophylaxis, surgical site management (skin preparation, debridement, and wound irrigation), provision of skeletal stability, and soft-tissue coverage. When it is applicable, strategies are differentiated between optimal resource and resource-limited settings.

Retrospective cohort study analyzing outcomes of the SIGN Fin Nail in adult femoral fractures using the retrograde approach.

Purpose: There is high burden of long bone fractures in low- and middle-income countries (LMICs). Given a limited availability of fluoroscopy in LMICs, the Surgical Implant Generation Network (SIGN) developed two types of intramedullary nails: the SIGN standard nail and the SIGN Fin Nail. A limited number of studies have analyzed healing outcomes with the SIGN Fin Nail and the current study is the largest one to date. The purpose of this study is to compare outcomes between the SIGN standard nail and SIGN Fin Nails in adult femoral shaft fractures treated with a retrograde approach. Method: A retrospective cohort study of adults with femoral shaft fractures was performed using the Sign Online Surgical Database (SOSD). The primary outcome was achieving full painless weight bearing and the secondary outcomes assessed were radiographic healing and infection. A propensity-score adjustment was performed for potential confounders and effect modification due to fracture location was tested using a Mantel-Haenszel test for heterogeneity. Results: Of 19,928 adults with femoral shaft fractures, 2,912 (14.7%) had the required 6-month follow-up to be included. The overall propensity score weighted relative risk between the Fin and Standard Nail for achieving painless weight-bearing was 0.99, 95% CI [0.96-1.03] and for radiographical healing was 0.99, 95%CI [0.97-1.02]. The propensity score weighted relative risk for infection was 1.30, 95% [0.85-1.97]. Use of the Fin nail was also significantly associated with shorter surgery times (p < 0.005, effect size = 24 min). Sub-group analysis based on fracture location and injury cause demonstrated no change in relative risk. Conclusion: The Fin nail showed no change in relative risk in terms of achieving full painless weightbearing or radiographic healing compared to the standard nail for retrograde nailing of femoral shaft fractures in adults. The heterogeneous nature of the cohort and large sample size allow for generalizability and add to a growing base of literature supporting use of the Fin Nail for retrograde femoral nailing. However, there are limitations as we could not correct for comminution at the fracture site or measure radiographic alignment or shortening.

Association between prolactin increasing antipsychotic use and the risk of breast cancer: a retrospective observational cohort study in a United States Medicaid population.

Introduction: Results of retrospective studies examining the relationship between prolactin increasing antipsychotics and incident breast cancer have been inconsistent. This study assessed the association between use of high prolactin increasing antipsychotics (HPD) and the incidence of breast cancer using best practices in pharmacoepidemiology. Methods: Using administrative claims data from the MarketScan Medicaid database, schizophrenia patients initiating antipsychotics were identified. Those initiating HPD were compared with new users of non/low prolactin increasing drugs (NPD). Two definitions of breast cancer, two at-risk periods, and two large-scale propensity score (PS) adjustment methods were used in separate analyses. PS models included all previously diagnosed conditions, medication use, demographics, and other available medical history. Negative control outcomes were used for empirical calibration. Results: Five analysis variants passed all diagnostics for sufficient statistical power and balance across all covariates. Four of the five variants used an intent-to-treat (ITT) approach. Between 4,256 and 6,341 patients were included in each group for the ITT analyses, and patients contributed approximately four years of follow-up time on average. There was no statistically significant association between exposure to HPD and risk of incident breast cancer in any analysis, and hazard ratios remained close to 1.0, ranging from 0.96 (95% confidence interval 0.62 - 1.48) to 1.28 (0.40 - 4.07). Discussion: Using multiple PS methods, outcome definitions and at-risk periods provided robust and consistent results which found no evidence of an association between use of HPD and risk of breast cancer.

Distal femur fractures: basic science and international perspectives.

Distal femur fractures are challenging injuries to manage, and complication rates remain high. This article summarizes the international and basic science perspectives regarding distal femoral fractures that were presented at the 2022 Orthopaedic Trauma Association Annual Meeting. We review a number of critical concepts that can be considered to optimize the treatment of these difficult fractures. These include biomechanical considerations for distal femur fixation constructs, emerging treatments to prevent post-traumatic arthritis, both systemic and local biologic treatments to optimize nonunion management, the relative advantages and disadvantages of plate versus nail versus dual-implant constructs, and finally important factors which determine outcomes. A robust understanding of these principles can significantly improve success rates and minimize complications in the treatment of these challenging injuries.

An Analysis of Participant Preferences Regarding Virtual Versus In-person Format of Orthopaedic Surgery Educational Materials in Low- and Middle-Income Countries.

INTRODUCTION: The University of California, San Francisco Institute for Global Orthopaedics and Traumatology Surgical Management and Reconstructive Training (SMART) course has instructed orthopaedic surgeons from low-resource countries on soft-tissue reconstruction. Before the COVID-19 pandemic, the course was conducted in-person; however, it was transitioned to a virtual format during the pandemic. The aim of this study was to determine participant preferences regarding a virtual or in-person SMART course format. METHODS: Survey data were collected via e-mail after each SMART course using RedCap or Qualtrics. Statistical analyses were conducted using Stata. RESULTS: There were 247 survey respondents from 44 countries representing all world regions, with Africa (125, 51%) the most represented. Of those who attended both an in-person and virtual course, most (82%) preferred the in-person format. In addition, all measured course outcomes were significantly better for participants attending the in-person course. The most common reason for not attending an in-person course was the cost of travel (38, 51%). DISCUSSION: This study demonstrated a preference toward in-person learning for the SMART course. In addition, those surgeons participating in the in-person course endorsed increased positive outcomes from the course. Increased emphasis should be placed on in-person surgical skills training for low-resource surgeons.

Estimating the economic impact of complications after open tibial fracture: A secondary analysis of the pilot Gentamicin Open Tibia trial (pGO-Tibia).

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.

Establishing Consensus on Essential Resources for Musculoskeletal Trauma Care Worldwide: A Modified Delphi Study.

BACKGROUND: Despite evidence that formalized trauma systems enhance patient functional outcomes and decrease mortality rates, there remains a lack of such systems globally. Critical to trauma systems are the equipment, materials, and supplies needed to support care, which vary in availability regionally. The purpose of the present study was to identify essential resources for musculoskeletal trauma care across diverse resource settings worldwide. METHODS: The modified Delphi method was utilized, with 3 rounds of electronic surveys. Respondents consisted of 1 surgeon with expertise in musculoskeletal trauma per country. Participants were identified with use of the AO Trauma, AO Alliance, Orthopaedic Trauma Association, and European Society for Trauma and Emergency Surgery networks. Respondents rated resources on a Likert scale from 1 (most important) to 9 (least important). The "most essential" resources were classified as those rated ≤2 by ≥75% of the sampled group. RESULTS: One hundred and three of 111 invited surgeons completed the first survey and were included throughout the subsequent rounds (representing a 93% response rate). Most participants were fellowship-trained (78%) trauma and orthopaedic surgeons (90%) practicing in an academic setting (62%), and 46% had >20 years of experience. Respondents represented low-income and lower-middle-income countries (LMICs; 35%), upper-middle income countries (UMICs; 30%), and high-income countries (HICs; 35%). The initial survey identified 308 unique resources for pre-hospital, in-hospital, and post-hospital phases of care, of which 71 resources achieved consensus as the most essential. There was a significant difference (p < 0.0167) in ratings between income groups for 16 resources, all of which were related to general trauma care rather than musculoskeletal injury management. CONCLUSIONS: There was agreement on a core list of essential musculoskeletal trauma care resources by respondents from LMICs, UMICs, and HICs. All significant differences in resource ratings were related to general trauma management. This study represents a first step toward establishing international consensus and underscores the need to prioritize resources that are locally available. The information can be used to develop effective guidelines and policies, create best-practice treatment standards, and advocate for necessary resources worldwide. CLINICAL RELEVANCE: This study utilized the Delphi method representing expert opinion; however, this work did not examine patient management and therefore does not have a clinical Level of Evidence.

Diagnostic Performance of a telephone questionnaire for fracture-related infections (FRIs) in open tibia fracture patients in Tanzania.

INTRODUCTION: Fracture-related infections (FRIs) are a major cause of trauma-associated morbidity worldwide. In 2018, an expert group supported by the AO Foundation, European Bone and Joint Infection Society developed a consensus definition of FRI. Still, there is limited knowledge on the applicability of this definition in low- and middle-income countries (LMICs). Given the unique barriers that cause low follow-up rates for orthopaedic trauma patients in LMICs, this study aims to evaluate the diagnostic performance of a telephone questionnaire in identifying patients with FRIs after open tibia fracture fixation in Tanzania. MATERIALS AND METHODS: Patients from a randomized controlled trial investigating the infection prevention benefit of locally applied gentamycin for open tibial fractures were included. Patients completed FRI based telephone questionnaires 7-10 days prior to scheduled follow-ups at 6 weeks, 3 months, 6 months, 9 months, and 1 year. The questionnaire included two "confirmatory" criteria questions for FRI (i.e., open wound and purulent drainage) and three "suggestive" criteria questions (i.e., wound drainage, fever, and warmth). Contingency tests were performed to identify the sensitivity and specificity between answers and adjudicated FRI diagnoses at the corresponding in-person follow-up. Data was analysed using STATA version 15.0 and MedCalc's online diagnostic test calculator. RESULTS: There were a total of 234 complete questionnaires and 85 unique patients included. The sensitivity and specificity of having any positive answer in the questionnaire was highest at 6 months (100 % and 92.5 %, respectively). For all time-points pooled, sensitivity was 71.4 % and specificity was 93.0 %. Drainage had the highest sensitivity (71.4 %) while fever had the highest specificity (99.6 %). For confirmatory criteria, sensitivity was 14.3 % and specificity was 96.0 %. Contrastingly, the sensitivity for suggestive criteria was higher (71.4 %), with a similar specificity (93.8 %). CONCLUSION: Our study indicates that telephone questionnaires have adequate diagnostic performance when assessing FRIs. The presence of drainage identified the majority of patients with FRI, and specificities were high across confirmatory and suggestive criteria. Our study is one of the first to evaluate telephone questionnaires as a diagnostic tool for FRIs in patients with open tibia fractures in a LMIC hospital and validates the FRI consensus definition criteria.

Best Practices for Developing International Academic Partnerships in Orthopaedics.

ABSTRACT: Traumatic and nontraumatic orthopaedic conditions are major contributors to global morbidity and account for the majority of life-years lived with disability worldwide. Additionally, the burden of musculoskeletal injuries has increased substantially over the past 3 decades. Unfortunately, in low and middle-income countries (LMICs), access to orthopaedic care is limited, leading to a disproportionate burden of disease. The Lancet Commission on Global Surgery has emphasized the urgent need for unified international commitment and research collaboration to achieve universal access to safe and affordable surgical care. However, conducting high-quality orthopaedic research in LMICs remains challenging as a result of disparities in training, access to resources, infrastructure, and equipment availability. Partnerships between high-income countries (HICs) and LMICs have emerged in recent decades as an effective approach to combatting some of these challenges. These partnerships aim to bridge the gaps by facilitating collaborative research and knowledge exchange. The establishment of successful partnerships requires a collaborative and reciprocal approach that starts with a clear understanding of mutual research aims and the availability of resources. Despite the potential benefits, various factors can make establishing such partnerships difficult. However, these partnerships can have a substantial impact in delivering quality orthopaedic education and research training, thus improving access to care in resource-limited environments. This paper represents the collaborative effort of multiple international academic orthopaedic surgeons with extensive experience in HIC-LMIC partnerships. Our aims were to outline the best practices for conducting orthopaedic research within these relationships and to provide guidance for future successful collaborations.

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

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.

Delays in Debridement of Open Femoral and Tibial Fractures Increase Risk of Infection.

BACKGROUND: Infection remains a costly, devastating complication following the treatment of open fractures. The appropriate timing of debridement is controversial, and available evidence has been conflicting. METHODS: This study is a retrospective analysis of the SIGN (Surgical Implant Generation Network) Surgical Database (SSDB), a prospective registry of fracture cases in predominantly low-resource settings. Skeletally mature patients (≥16 years of age) who returned for follow-up at any time point after intramedullary nailing of an open femoral or tibial fracture were included. Patients were excluded if they had delays in debridement exceeding 7 days after the injury. Utilizing a model adjusting for potential confounders, including patient demographic characteristics, injury characteristics, country income level, and hospital type and resources, local logistic regression analysis was performed to evaluate the probability of infection with increasing time to debridement in 6-hour increments. RESULTS: In this study, 27.3% of patients met the eligibility criteria and returned for follow-up, with a total of 10,651 fractures from 61 countries included. Overall, the probability of infection increased by 0.17% for every 6-hour delay in debridement. On subgroup analysis, the probability of infection increased by 0.23% every 6 hours for Gustilo-Anderson type-III injuries compared with 0.13% for Gustilo-Anderson type-I or II injuries. The infection risk increased every 6 hours by 0.18% for tibial fractures compared with 0.13% for femoral fractures. CONCLUSIONS: There was a linear and cumulative increased risk of infection with delays in debridement for open femoral and tibial fractures. Such injuries should be debrided promptly and expeditiously. The size and international nature of this cohort make these findings uniquely generalizable to nearly all environments where such injuries are treated. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Pilon fractures: Consensus and controversy.

Pilon fractures are complex injuries that require an individualized approach to treatment to avoid complications and achieve good outcomes. Staged open reduction internal fixation remains the gold standard for most cases to achieve anatomic articular reduction while minimizing soft tissue complications and infection. Careful preoperative planning based on computed tomography dictates the surgical approach for reduction. A subset of cases may be amenable to early definitive or provisional open reduction and internal fixation based on fracture pattern. In some cases of severe articular comminution where reconstruction is not possible, primary ankle arthrodesis may be a good alternative.

Predictors of nonunion for transverse femoral shaft fractures treated with intramedullary nailing: a SIGN database study.

Introduction: Nonunion is a common postfracture complication resulting in decreased quality of life for patients in resource-limited settings. This study aims to determine how age, sex, injury mechanism, and surgical intervention affect the rate of nonunion in transverse femur fractures treated with a SIGN intramedullary nail (IMN). Methods: A retrospective study was conducted using the SIGN online surgical database. All patients older than 16 years with simple transverse (<30 degrees), open or closed, femur fractures treated using a SIGN IMN between 2007 and 2021 were included. Our primary outcome of nonunion was measured with the modified Radiographic Union Scale for Tibial fractures (mRUST); scores ≤9 of 16 defined nonunion. The secondary outcome was squat depth. Outcomes were evaluated at follow-up appointments between 240 and 365 days postoperatively. Univariate and multivariate analysis were used for statistical comparison. Results: Inclusion criteria were met for 182 patients. The overall radiographic union rate was 61.0%, and a high proportion (84.4%) of patients could squat with their hips at or below the level of their knees. Older age, retrograde approach, and fracture distraction were associated with nonunion, but sex, injury mechanism, and other surgical variables were not. Conclusion: Poor reduction with fracture distraction was associated with a higher rate of nonunion. Loss of follow-up may have contributed to our overall union rate; however, we observed high rates of functional healing using the SIGN IMN. Level of evidence: IV.

Novel e-learning platform for orthopaedic training in LMICs: A descriptive review of the IGOT portal.

Background: While e-learning has been written about extensively within the context of orthopaedics in the United States, there are few articles describing e-learning initiatives geared towards low-and middle-income countries (LMICs). The Institute for Global Orthopaedics and Traumatology (IGOT) at the University of California, San Francisco (UCSF) developed the IGOT Learning Portal to meet this need. Methods: The IGOT Learning Portal was designed to address knowledge gaps in patient care by increasing access to high-quality orthopaedic education for surgeons and trainees worldwide. It offers 10 distinct, asynchronous courses, which are divided into a modular format. Course enrollment is free and accessible to any surgeon or trainee with a web-browsing capable device and internet connection. Results: There are more than 2700 registered users and 300 active learners enrolled in IGOT Learning Portal courses. The Surgical Management and Reconstructive Training (SMART) program is the most commonly taken course. Learners represent 32 different countries across six continents. The IGOT portal also has surgical videos available on YouTube. The IGOT Portal YouTube channel has over 2000 subscribers and over 143,000 total views. Conclusions: The IGOT Learning Portal is an innovative approach to address the global disparity in orthopaedic trauma care by improving access to high-quality surgical education for surgeons and trainees both in the US and internationally. The development of an interactive online forum may be a beneficial addition to the Portal. Future directions include assessing content retention, participant interaction, and expanding existing content to other orthopaedic subspecialties.

GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures.

BACKGROUND: The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different. METHODS: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up. DISCUSSION: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures. TRIAL REGISTRATION: Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Simple design and analysis strategies for solving problems in observational orthopaedic clinical research.

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.

Transfemoral amputation and prosthesis provision in Tanzania: Patient and provider perspectives.

Background: The burden of disability because of traumatic limb amputation, particularly transfemoral amputation (TFA) is disproportionately carried by low- and middle-income countries. The need for improved access to prosthesis services in these settings is well-documented, but perspectives on the burden imposed by TFA and the challenges associated with subsequent prosthesis provision vary among patients, caregivers and healthcare providers. Objectives: To examine the burden of TFA and barriers to prosthesis provision as perceived by patient, caregiver and healthcare professional, at a single tertiary referral hospital in Tanzania. Method: Data were collected from five patients with TFA and four caregivers recruited via convenience sampling, in addition to 11 purposively sampled healthcare providers. All participants participated in in-depth interviews regarding their perceptions of amputation, prostheses and underlying barriers to improving care for persons with TFA in Tanzania. A coding schema and thematic framework were established from interviews using inductive thematic analysis. Results: All participants noted financial and psychosocial burdens of amputation, and perceived prostheses as an opportunity for return to normality and independence. Patients worried about prosthesis longevity. Healthcare providers noted significant obstacles to prosthesis provision, including infrastructural and environmental barriers, limited access to prosthetic services, mismatched patient expectations and inadequate coordination of care. Conclusion: This qualitative analysis identifies factors influencing prosthesis-related care for patients with TFA in Tanzania which are lacking in the literature. Persons with TFA and their caregivers experience numerous hardships exacerbated by limited financial, social and institutional support. Contribution: This qualitative analysis informs future directions for research into improving prosthesis-related care for patients with TFA in Tanzania.