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.

Clinic follow-up of orthopaedic trauma patients during and after the post-surgical global period: a retrospective cohort study.

BACKGROUND: Insurance status is important as medical expenses may decrease the likelihood of follow-up after musculoskeletal trauma, especially for low-income populations. However, it is unknown what insurance factors are associated with follow-up care. In this study, we assessed the association between insurance plan benefits, the end of the post-surgical global period, and follow-up after musculoskeletal injury. METHODS: This is a retrospective cohort study of 394 patients with isolated extremity fractures who were treated at three level-I trauma centers over four months in 2018. Paired t-tests were utilized to assess the likelihood of follow-up in relation to the 90-day post-surgical global period. Regression analysis was used to assess factors associated with the likelihood of follow-up. Supervised machine learning algorithms were used to develop predictive models of follow-up after the post-surgical global period. RESULTS: Our final analysis included 328 patients. Likelihood of follow-up did not significantly change while within the post-surgical global period. When comparing follow-up within and outside of the post-surgical global period, there was a 20.1% decrease in follow-up between the 6-weeks and 6-month time points (68.3% versus 48.2%, respectively; p < 0.0001). Medicaid insurance compared to Medicare (OR 0.27, 95% confidence interval (CI) = [0.09, 0.84], p = 0.02) was a predictor of decreased likelihood of follow-up at 6-months post-operatively. CONCLUSIONS: Our study demonstrates a statistically significant decrease in follow-up for orthopaedic trauma patients after the post-surgical global period, particularly for patients with Medicaid or Private insurance.

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.

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.

The efficacy of an anti-protrusio plate in patients with anterior column posterior hemitransverse and associated both column acetabular fractures.

INTRODUCTION: Acetabular fractures in the elderly population are particularly challenging for orthopedic fracture surgeons to treat. Anterior column posterior hemitransverse (ACH) and both column (BC) fractures account for over 70% of these injuries in geriatric patients. Nonoperative management of these injuries has a mortality of about 79% and patients generally have a minimal chance of return to independent living. The aim of our study was to identify the degree of protrusio deformity geriatric patients with these injuries present with and if indirect reduction through a Stoppa approach was sufficient to improve protrusio deformity. METHODS: Patients older than 60 years of age who had ACH and BC pattern acetabular fractures treated at the BIDMC in Boston, MA between 2015 and 2020 were included in this study. Pelvic AP and Judet views were reviewed at injury and each available post-operative follow up. We modified the femoral head extrusion index and used its inverse to measure the level of protrusio at each time point (-FHEI). Patient outcomes were also graded as excellent, good, fair and poor based on post-operative follow up. RESULTS: Sixteen patients were included based on above criteria and average -FHEI at injury was 34.85% and decreased significantly to an average of 21.5% postoperatively and remained stable at all follow up points. At one year follow up (n = 2), the mean -FHEI was 18.15%. Most patients had good (4) or excellent (9) outcomes. CONCLUSIONS: We present short term results of indirect reduction of ACH and BC acetabular fractures in geriatric patients using a PRO quadrilateral surface plate, which was largely successful in controlling the primary protrusio deformity seen in these patients. This allowed for restoration of the anterior column, with limited surgical morbidity through a relatively simple and straightforward surgical approach.

Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibial Fractures in Tanzania: Results of a Randomized Clinical Trial.

BACKGROUND: Open tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures. METHODS: We conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST). RESULTS: Of the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013). CONCLUSIONS: To our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Early treatment of open diaphyseal tibia fracture with intramedullary nail versus external fixator in Tanzania: Cost effectiveness analysis using preliminary data from Muhimbili Orthopaedic Institute.

INTRODUCTION: Open tibia fractures are some of the most common types of Orthopedics injuries in low- and middle-income countries (LMICs). In Tanzania, open tibia fractures are treated either conservatively by prolonged cast or surgically by external fixation (EF) or intramedullary nail (IMN) when available. The cost of treatment and amount of time patients spend away from work are major economic concerns with prolonged casting and EF. The goal of this study was to determine the cost effectiveness of IMN versus EF in the treatment of open diaphyseal tibia fractures at Muhimbili Orthopaedic Institute (Dar es Salaam, Tanzania). METHODS: This is a prospective randomized control study conducted of patients with a closeable AO/OTA 42 open diaphyseal tibia fracture. The patients underwent surgical fixation with either IMN or EF at Muhimbili Orthopaedic Institute (MOI), and were followed up at 2, 6, and 12 weeks postoperatively. A micro-costing method was used to estimate the fixed and variable costs of IMN and EF of the open diaphyseal tibial fracture. RESULTS: The mean total cost per patient was lower for the IMN group ($425.8 ± 38.4) compared to the EF group ($559.6 ± 70.5, p < 0.001), with savings of $133.80 per patient for the IMN group. The mean hospital stay was 2.72 ± 1.40 days for the IMN group and 2.44 ± 1.47 days for the EF group (p = 0.5). Quality-adjusted life years (QALYs) were 0.26 per patient for the IMN group and 0.24 in the EF group at 12 weeks (p = 0.8). Ninety-two percent of patients in the IMN group achieved fracture union versus 60% in the EF group at three months postoperatively (p = 0.03). CONCLUSION: IM nailing of a closeable open diaphyseal tibial fracture is more cost effective than EF. In addition, IM nailing has better union rates at three months compared to EF.

Development of Squat-and-Smile Test as Proxy for Femoral Shaft Fracture-Healing in Patients in Dar es Salaam, Tanzania.

BACKGROUND: There are few validated instruments that serve as a proxy for fracture-healing after lower-extremity trauma in low-resource settings. The squat-and-smile test (S&S) has been under development by SIGN (Surgical Implant Generation Network) Fracture Care International to monitor outcomes of lower-extremity long-bone fractures after intramedullary nailing in resource-limited settings. The goals of this study were to develop and identify domains of the S&S test. METHODS: The S&S domains were developed through an iterative process, and consensus was achieved regarding 3: squat depth, support needed to squat, and facial expression. Adult patients with an OTA/AO type-32 femoral shaft fracture were included in this retrospective study and had the S&S administered at 6 weeks and 3, 6, and 12 months postoperatively. Two authors independently assessed photographs of the patients performing the S&S. S&S domains were correlated with the EuroQol 5-Dimensions (EQ-5D) index score, and comparisons were made between S&S domains and reoperation status. Interrater and test-retest reliability was assessed using the kappa statistic. Sensitivity and specificity analyses were performed. RESULTS: Six hundred and nine S&S images were evaluated for 231 patients. Each domain improved over time and correlated positively with EQ-5D scores (p < 0.05). Squat depth and support needed to squat correlated with the need for a reoperation (p ≤ 0.01), and both had high specificity (0.95 and 0.97, respectively) for ruling out the need for a reoperation at 1 year. All 3 domains had high test-retest reliability (κ = 0.95, 0.92, and 0.96). Squat depth and need for support also had strong interrater reliability (κ = 0.75 and 0.78). CONCLUSIONS: The S&S is a potential tool for monitoring clinical and functional outcome of femoral shaft fractures in low-resource settings. Our data support the binary assessment of squat depth and need for support, but not facial expression, as a proxy for fracture-healing. Future prospective studies in external populations are warranted to evaluate the validity, reliability, and responsiveness of the S&S. CLINICAL RELEVANCE: The S&S provides a valuable proxy for femoral shaft fracture assessment for middle to low-income countries because it is locally relevant (based on squatting), it is easy to administer, and assessment can be performed remotely via mobile telephone or text messaging.

Muscle Microvascular Blood Flow, Oxygenation, pH, and Perfusion Pressure Decrease in Simulated Acute Compartment Syndrome.

BACKGROUND: The current gold standard for diagnosing acute compartment syndrome (ACS) is an assessment of clinical signs, invasive measurement of intramuscular pressure (IMP), and measurement of local perfusion pressure. However, IMP measurements have several shortcomings, including pain, risk of infection, risk of technique error, plugging of the catheter tip, lack of consensus on the diagnostic pressure threshold, and lack of specificity and sensitivity. The objective of this study was to evaluate muscle hemodynamics, oxygenation, and pH as diagnostic parameters in a human model of ACS. We hypothesized that as IMP increases, muscle microvascular blood flow, oxygenation, and pH decrease in the anterior compartment of a leg at heart level and that they decrease significantly more when the leg is elevated further. METHODS: An external pneumatic leg pressure chamber, combined with a venous stasis thigh cuff, was used to increase IMP and simulate ACS. Eight healthy subjects (5 males and 3 females; mean age, 26 years) had photoplethysmography and near-infrared spectroscopy-pH sensors placed over the middle aspect of the tibialis anterior muscle of the right (experimental) and left (control) legs. Leg chamber pressure conditions (40, 50, and 60 mm Hg) were applied in a randomized order after baseline measurements were taken. Data were collected continuously for each 11-minute pressure condition, with an 11-minute recovery period after each condition, and the average of the last 6 minutes was used for data analyses. The same protocol was repeated with each subject's legs elevated 12 cm above heart level. Data were analyzed using repeated-measures analysis of variance (ANOVA). RESULTS: As IMP increased, muscle microvascular blood flow (p = 0.01), oxygenation (p < 0.001), and pH (p < 0.001) all decreased significantly in the experimental leg compared with the control leg. At all IMP levels, leg elevation significantly decreased muscle oxygenation (p = 0.013) and perfusion pressure (p = 0.03) compared with the control leg at heart level. CONCLUSIONS: These results indicate that muscle microvascular blood flow, oxygenation, pH, and perfusion pressure decrease significantly as IMP increases in a human model of ACS. CLINICAL RELEVANCE: This study identifies hemodynamic and metabolic parameters as potential noninvasive diagnostic tools for ACS.