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.

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.

Determining Critical Topics for Undergraduate Surgical Education in Rwanda: Results of a Modified Delphi Process and a Consensus Conference.

Background Developing a contextually appropriate curriculum is critical to train physicians who can address surgical challenges in sub-Saharan Africa. An innovative modified Delphi process was used to identify contextually optimized curricular content to meet sub-Saharan Africa and Rwanda's surgical needs. Methods Participants were surgeons from East, Central, Southern, and West Africa and general practitioners with surgical experience. Delphi participants excluded or prioritized surgical topic areas generated from extensive grey and formal literature review. Surgical educators first screened and condensed identified topics. Round 1 screened and prioritized identified topics, with a 75% consensus cut-off based on the content validity index and a prioritization score. Topics that reached consensus were screened again in round 2 and re-prioritized, following controlled feedback. Frequencies for aggregate prioritization scores, experts in agreement, item-level content validity index, universal agreement and scale-level content validity index based on the average method (S-CVI/Ave) using proportion relevance, and intra-class correlation (ICC) (based on a mean-rating, consistency, two-way mixed-effects model) were performed. We also used arithmetic mean values and modal frequency. Cronbach's Alpha was also calculated to ascertain reliability. Results were validated through a multi-institution consensus conference attended by Rwanda-based surgical specialists, general practitioners, medical students, surgical educators, and surgical association representatives using an inclusive, participatory, collaborative, agreement-seeking, and cooperative, a priori consensus decision-making model. Results Two-hundred and sixty-seven broad surgical content areas were identified through the initial round and presented to experts. In round 2, a total of 247 (92%) content areas reached 75% consensus among 31 experts. Topics that did not achieve consensus consisted broadly of small intestinal malignancies, rare hepatobiliary pathologies, and transplantation. In the final round, 99.6% of content areas reached 75% consensus among 31 experts. The highest prioritization was on wound healing, fluid and electrolyte management, and appendicitis, followed by metabolic response, infection, preoperative preparation, antibiotics, small bowel obstruction and perforation, breast infection, acute urinary retention, testicular torsion, hemorrhoids, and surgical ethics. Overall, the consistency and average agreement between panel experts was strong. ICC was 0.856 (95% CI: 0.83-0.87). Cronbach's Alpha for round 2 was very strong (0.985, 95% CI: 0.976-0.991) and higher than round 1, demonstrating strong reliability. All 246 topics from round 4 were verbally accepted by 40 participants in open forum discussions during the consensus conference. Conclusions A modified Delphi process and consensus were able to identify essential topics to be included within a highly contextualized, locally driven surgical clerkship curriculum delivered in rural Rwanda. Other contexts can use similar processes to develop relevant curricula.

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.

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.

Outcomes of Intramedullary Nailing and External Fixation of Open Tibial Fractures: Three to Five-Year Follow-up of a Randomized Clinical Trial.

BACKGROUND: While surgeons in low and middle-income countries have increasing experience with intramedullary nailing (IMN), external fixation (EF) continues to be commonly used for the management of open tibial fractures. We examined outcomes with extended follow-up of the participants enrolled in a clinical trial comparing these treatments. METHODS: Adults who were ≥18 years old with acute AO/OTA type-42 open tibial shaft fractures were randomly assigned to statically locked, hand-reamed IMN or uniplanar EF. These participants were reevaluated 3 to 5 years after treatment. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Unresolved complications such as persistent fracture-related infection, nonunion, or malalignment were collected and analyzed. Secondary outcomes included the EuroQol-5 Dimension-3 Level (EQ-5D-3L) questionnaire, the Function IndeX for Trauma (FIX-IT) score, radiographic alignment, and the modified Radiographic Union Scale for Tibial fractures (mRUST). RESULTS: Of the originally enrolled 240 participants,126 (67 managed with IMN and 59 managed with EF) died or returned for follow-up at a mean of 4.0 years (range, 2.9 to 5.2 years). Thirty-two composite primary events occurred, with rates of 23.9% and 27.1% in the IMN and EF groups, respectively. Six of these events (3 in the IMN group and 3 in the EF group) were newly detected after the original 1-year follow-up. Unresolved complications in the form of chronic fracture-related infection or nonunion were present at long-term follow-up in 25% of the participants who sustained a primary event. The EQ-5D-3L index scores were similar between the 2 groups and only returned to preinjury levels after 1 year among patients without complications or those whose complications resolved. CONCLUSIONS: This observational study extended follow-up for a clinical trial assessing IMN versus EF for the treatment of open tibial fractures in sub-Saharan Africa. At a mean of 4 years after injury, fracture-related infection and nonunion became chronic conditions in nearly a quarter of the participants who experienced these complications, regardless of reintervention. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Host Perspectives of High-Income Country Orthopaedic Resident Rotations in Low and Middle-Income Countries.

BACKGROUND: International orthopaedic resident rotations in low and middle-income countries (LMICs) are gaining popularity among high-income country (HIC) residency programs. While evidence demonstrates a benefit for the visiting residents, few studies have evaluated the impact of such rotations on the orthopaedic surgeons and trainees in LMICs. The purpose of this study was to further explore themes identified in a previous survey study regarding the local impact of visiting HIC resident rotations. METHODS: Using a semistructured interview guide, LMIC surgeons and trainees who had hosted HIC orthopaedic residents within the previous 10 years were interviewed until thematic saturation was reached. RESULTS: Twenty attending and resident orthopaedic surgeons from 8 LMICs were interviewed. Positive and negative effects of the visiting residents on clinical care, education, interpersonal relationships, and resource availability were identified. Seven recommendations for visiting resident rotations were highlighted, including a 1 to 2-month rotation length; visiting residents at the senior training level; site-specific prerotation orientation with an emphasis on resident attitudes, including the need for humility; creation of bidirectional opportunities; partnering with institutions with local training programs; and fostering mutually beneficial sustained relationships. CONCLUSIONS: This study explores the perspectives of those who host visiting residents, a viewpoint that is underrepresented in the literature. Future research regarding HIC orthopaedic resident rotations in LMICs should include the perspectives of local surgeons and trainees to strive for mutually beneficial experiences to further strengthen and sustain such academic partnerships.

Establishing Sustainable Arthroscopy Capacity in Low- and Middle-Income Countries (LMICs) through High-Income Country/LMIC Partnerships: A Qualitative Analysis.

Disparities exist in treatment modalities, including arthroscopic surgery, for orthopaedic injuries between high-income countries (HICs) and low- and middle-income countries (LMICs). Arthroscopy training is a self-identified goal of LMIC surgeons to meet the burden of musculoskeletal injury. The aim of this study was to determine the necessary "key ingredients" for establishing arthroscopy centers in LMICs in order to build capacity and expand training in arthroscopy in lower-resource settings. Methods: This study utilized semi-structured interviews with orthopaedic surgeons from both HICs and LMICs who had prior experience establishing arthroscopy efforts in LMICs. Participants were recruited via referral sampling. Interviews were qualitatively analyzed in duplicate via a coding schema based on repeated themes from preliminary interview review. Subgroup analysis was conducted between HIC and LMIC respondents. Results: We identified perspectives shared between HIC and LMIC stakeholders and perspectives unique to 1 group. Both groups were motivated by opportunities to improve patients' lives; the LMIC respondents were also motivated by access to skills and equipment, and the HIC respondents were motivated by teaching opportunities. Key ingredients identified by both groups included an emphasis on teaching and the need for high-cost equipment, such as arthroscopy towers. The LMIC respondents reported single-use materials as a key ingredient, while the HIC respondents reported local champions as crucial. The LMIC respondents cited the scarcity of implants and shaver blades as a barrier to the continuity of arthroscopy efforts. Conclusions: Incorporation of the identified key ingredients, along with leveraging the motivations of the host and the visiting participant, will allow future international arthroscopy partnerships to better match proposed interventions with the host-identified needs. Clinical Relevance: Arthroscopy is an important tool for treatment of musculoskeletal injury. Increasing access to arthroscopy is an important goal to achieve greater equity in musculoskeletal care globally. Developing successful partnerships between HICs and LMICs to support arthroscopic surgery requires sustained relationships that address local needs.

Reliability of Modified Radiographic Union Score for Tibia Scores in the Evaluation of Femoral Shaft Fractures in a Low-resource Setting.

INTRODUCTION: The modified Radiographic Union Score for Tibia (RUST) fractures was developed to better describe fracture healing, but its utility in resource-limited settings is poorly understood. This study aimed to determine the validity of mRUST scores in evaluating fracture healing in diaphyseal femur fractures treated operatively at a single tertiary referral hospital in Tanzania. METHODS: Radiographs of 297 fractures were evaluated using the mRUST score and compared with outcomes including revision surgery and EuroQol five dimensions questionnaire (EQ-5D) and visual analog scale (VAS) quality-of-life measures. Convergent validity was assessed by correlating mRUST scores with EQ-5D and VAS scores. Divergent validity was assessed by comparing mRUST scores in patients based on revision surgery status. RESULTS: The mRUST score had moderate correlation (Spearman correlation coefficient 0.40) with EQ-5D scores and weak correlation (Spearman correlation coefficient 0.320) with VAS scores. Compared with patients who required revision surgery, patients who did not require revision surgery had higher RUST scores at all time points, with statistically significant differences at 3 months (2.02, P < 0.05). DISCUSSION: These results demonstrate that the mRUST score is a valid method of evaluating the healing of femoral shaft fractures in resource-limited settings, with high interrater reliability, correlation with widely used quality of life measures (EQ-5D and VAS), and expected divergence in the setting of complications requiring revision surgery.

Cost-effectiveness analysis of prosthesis provision for patients with transfemoral amputation in Tanzania.

BACKGROUND: Limb loss leads to significant disability. Prostheses may mitigate this disability but are not readily accessible in low- and middle-income countries (LMICs). Cost-effectiveness data related to prosthesis provision in resource-constrained environments such as Tanzania is greatly limited. OBJECTIVES: This study aimed to compare the cost-effectiveness of a prosthesis intervention compared with that of no prosthesis for persons with transfemoral amputations in an LMIC. STUDY DESIGN: This is a prospective cohort study. METHODS: Thirty-eight patients were prospectively followed up. Clinical improvement with prosthesis provision was measured using EuroQuol-5D, represented as quality-adjusted life years gained. Direct and indirect costs were measured. The primary outcome was incremental cost per quality-adjusted life year, measured at 1 year and projected over a lifetime using a Markov model. Reference case was set as a single prosthesis provided without replacement from a payer perspective. Additional scenarios included the societal perspective and replacement of the prosthesis. Uncertainty was measured with one-way probabilistic sensitivity analysis. RESULTS: From the payer perspective, the incremental cost-effectiveness ratio (ICER) was $242 for those without prosthetic replacement over a lifetime, and the ICER was $390 for those with prosthetic replacement over a lifeime. From the societal perspective, prosthesis provision was both less expensive and more effective. One-way sensitivity analysis demonstrated the ICER remained below the willingness to pay threshold up to prosthesis costs of $763. CONCLUSIONS: These findings suggest prosthesis provision in an LMIC may be cost-effective, but further studies with long-term follow up are needed to validate the results.

Assessment of clinical and radiographic outcomes following retrograde versus antegrade nailing of infraisthmic femoral shaft fractures without the use of intraoperative fluoroscopy in Tanzania.

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.

Intramedullary nailing versus external fixation for open tibia fractures in Tanzania: a cost analysis.

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.

Impact of prostheses on quality of life and functional status of transfemoral amputees in Tanzania.

BACKGROUND: The rise of diabetes and traumatic injury has increased limb loss-related morbidity in low- and middle-income countries (LMICs). Despite this, the majority of amputees in LMICs have no access to prosthetic devices, and the magnitude of prosthesis impact on quality of life (QOL ) and function has not been quantified. OBJECTIVES: Quantify the impact of prostheses on QOL and function in Tanzanian transfemoral amputees. METHOD: A prospective cohort study was conducted. Transfemoral amputees at Muhimbili Orthopaedic Institute were assessed twice before and three times after prosthetic fitting using EuroQol-5D-3L (EQ-5D-3L), Prosthetic Limb Users Survey of Mobility (PLUS-M), 2-minute walk test (2MWT) and Physiologic Cost Index (PCI). Data were analysed for change over time. Subgroup analysis was performed for amputation aetiology (vascular or non-vascular) and prosthesis use. RESULTS: Amongst 30 patients, EQ-5D, PLUS-M and 2MWT improved after prosthesis provision (p < 0.001). EuroQol-5D increased from 0.48 to 0.85 at 1 year (p < 0.001). EuroQol-5D and 2MWT were higher in non-vascular subgroup (p < 0.030). At 1-year, 84% of non-vascular and 44% of vascular subgroups reported using their prosthesis (p = 0.068). CONCLUSION: Prosthesis provision to transfemoral amputees in an LMIC improved QOL and function. This benefit was greater for non-vascular amputation aetiologies. Quality of life and function returned to pre-prosthesis levels with discontinued use of prosthesis.

Evaluating reliability and validity of the modified radiographic union scale for tibia (mRUST) among North American and Tanzanian surgeons.

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.

A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania.

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.

Monoplanar external fixation of comminuted open tibial shaft fractures predicts loss of alignment by one year compared to a statically locked intramedullary SIGN nail.

AIMS: This investigation develops a predictive model for loss of alignment (LOA) following fixation of open tibia fractures. PATIENTS/METHODS: An analysis was performed of adults with diaphyseal open tibia fractures randomized to intramedullary nailing (IMN) or external fixation (EF) followed at 6, 12, 24, and 52 weeks postoperatively. Demographic data were collected at baseline. Pre-injury and follow-up EuroQol 5-Dimensions (EQ-5D) and pain score were measured. Radiographs, taken postoperatively and in follow-up, were assessed for coronal and sagittal angulation, and used to calculate the modified Radiographic Union Scale for Tibia fractures (mRUST). LOA was defined as an increase in angulation >5° by one year follow-up. Fracture comminution was defined using AO/OTA classification. Putative risk factors were assessed for association with LOA using bivariate logistic regression. Adjusted associations with LOA were estimated using multivariable logistic regression and marginal analysis. RESULTS: Analyses included 129 patients (70 IMN, 59 EF), majority male, of mean age 33 years (range 17.7-73) and body mass index (BMI) 25.2 (range 15.5-45.1), with 48% Type A, 41% Type B, and 11% Type C fractures (AO/OTA classification). The likelihood of LOA with EF increased with greater fracture comminution; 45.21% (p<0.001), 77.50% (p<0.001), and 100% LOA for Type A, B, and C fractures respectively. Relative risk of LOA for EF compared to IMN was 3.87 (95% CI 1.36, 11.02), 3.75 (95% CI 1.77, 7.92), and 5.76 for Type A, B, and C fractures, respectively. Compared to patients who lost alignment, patients without LOA had improved fracture healing (p = 0.003) and higher EQ-5D scores (p = 0.03) at one year. CONCLUSION: Increasing age and BMI are associated with LOA and segmental fracture amplifies the protective effect of IMN versus EF. The importance of LOA as a surrogate outcome after operative treatment of open tibial fractures is supported by its association with inferior radiographic and functional patient outcomes.

Resident Rotations in Low- and Middle-Income Countries: Motivations, Impact, and Host Perspectives.

Interest in clinical rotations in low- and middle-income countries (LMICs) has grown among high-income country (HIC) orthopaedic residents. This study addresses the following questions: (1) What motivates HIC surgical residents to rotate in LMICs? (2) What is the impact of rotations on HIC residents? (3) What are the LMIC partner perceptions of HIC collaboration? MATERIALS AND METHODS: A search strategy of multiple databases returned 3,740 unique articles pertaining to HIC surgical resident motivations for participating in rotations in LMICs or the LMIC host perspective. Data extraction was dually performed using meta-ethnography, the qualitative equivalent of meta-analysis. RESULTS: Twenty-one studies were included in the final analysis. HIC residents were primarily motivated to rotate in LMICs by altruistic intent, with greatest impact on professional development. LMIC partners mostly valued HIC sustained investment and educational opportunities for LMIC partners. From LMIC's perspective, potential harm from collaboration arose from system-level and individual-level discordance between HIC and LMIC expectations and priorities. HIC priorities included the following: (1) adequate operative time, (2) exposure to varied pathology, and (3) mentorship. LMIC priorities included the following: (1) avoiding competition with HIC residents for surgical cases, (2) that HIC groups not undermine LMIC internal authority, (3) that HIC initiatives address local LMIC needs, and (4) that LMIC partners be included as authors on HIC research initiatives. Both HIC and LMIC partners raised ethical concerns regarding collaboration and perceived HIC residents to be underprepared for their LMIC rotation. DISCUSSION: This study synthesizes the available literature on HIC surgical resident motivations for and impact of rotating in LMICs and the LMIC host perception of collaboration. Three improvement categories emerged: that residents (1) receive site-specific preparation before departure, (2) remain in country long enough to develop site-specific skills, and (3) cultivate flexibility and cultural humility. Specific suggestions based on synthesized data are offered for each concept and can serve as a foundation for mutually beneficial international electives in LMICs for HIC orthopaedic trainees.

Delays to Surgery and Coronal Malalignment Are Associated with Reoperation after Open Tibia Fractures in Tanzania.

BACKGROUND: Treatment of diaphyseal open tibia fractures often results in reoperation and impaired quality of life. Few studies, particularly in resource-limited settings, have described factors associated with outcomes after these fractures. QUESTIONS/PURPOSES: (1) Which patient demographic, perioperative, and treatment characteristics are associated with an increased risk of reoperation after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? (2) Which patient demographic, perioperative, and treatment characteristics are associated with worse 1-year quality of life after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? METHODS: A prospective study was completed in parallel to a similarly conducted RCT at a tertiary referral center in Tanzania that enrolled adult patients with diaphyseal open tibia fractures from December 2015 to March 2017. Patients were treated with either a statically locked intramedullary nail or external fixator and examined at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The primary outcome, reoperation, was any deep infection or nonunion treated with a secondary intervention. The secondary outcome was the 1-year EuroQol-5D (EQ-5D) index score. There were 394 patients screened and ultimately, 267 patients enrolled in the study (240 from the primary RCT and 27 followed for the purposes of this study). Of these, 90% (240 of 267) completed 1-year follow-up and were included in the final analysis. This group comprised 110 patients who underwent IMN and 130 who had external fixation; follow-up was similar between study groups. Patients were an average of 33 years old and were primarily males who sustained road traffic injuries resulting in AO/Orthopaedic Trauma Association (OTA) classification type A or B fractures. There were 51 reoperations. For the purposes of analysis, all patients were pooled to identify all other factors, in addition to treatment type, associated with increased risk of reoperation and 1-year quality of life. An exploratory bivariable analysis identifying various factors associated with reoperation risk and EQ-5D was subsequently included in a multivariate modeling procedure to control for confounding of effect on our primary outcome. Multivariable modeling was performed using standard hierarchical modeling simplification procedures with log-likelihood ratios. Alpha levels were set to 0.05. RESULTS: After controlling for potentially confounding variables such as gender, smoking status, mechanism of injury, and treatment type, the following factors were independently associated with reoperation: Time from hospital presentation to surgery more than 24 hours (odds ratio 7.7 [95% confidence interval 2.1 to 27.8; p = 0.002), AO/OTA fracture classification Type 42C fracture (OR 4.2 [95% CI 1.2 to 14.0]; p = 0.02), OTA-Open Fracture Classification muscle loss (OR 7.5 [95% CI 1.3 to 42.2]; p = 0.02), and varus coronal angle on an immediate postoperative AP radiograph (OR 4.8 [95% CI 1.2 to 14.0]; p = 0.002). After again controlling for confounding variables such as gender, smoking status, mechanism of injury, and treatment type factors independently associated with worse 1-year EQ-5D scores included: Wound length ≥ 10 cm (ß = [change in EQ-5D score] -0.081 [95% CI -0.139 to -0.023]; p = 0.006), OTA-Open Fracture Classification muscle loss (ß = -0.133 [95% CI -0.215 to -0.051]; p = 0.002), and OTA-Open Fracture Classification bone loss (ß = -0.111 [95% CI -0.208 to -0.013]; p = 0.03). We observed a modest, but independent association between reoperation and worse 1-year EQ-5D scores (ß = -0.113 [95% CI -0.150 to -0.077]; p < 0.001). CONCLUSIONS: We found two potentially modifiable factors associated with the risk of reoperation: reducing time to surgical treatment and avoiding varus coronal angulation during definitive stabilization. Hospitals may be able to minimize time to surgery, and thus, reoperation, by increasing the number of available operative personnel and space and emphasizing the importance of open tibia fractures as an injury requiring emergent orthopaedic management. Given the lack of fluoroscopy in the study setting and similar settings, surgeons should emphasize appropriate fracture alignment, even into slight valgus, to avoid varus angulation and subsequent reoperation risk. LEVEL OF EVIDENCE: Level II, therapeutic study.