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.
Introduction: Investigations are rapidly increasing into products referred to as orthobiologics and their utility in the nonsurgical and surgical treatment of diverse orthopaedic pathology. Methods: Members (599) of the American Orthopaedic Society for Sports Medicine were sent a survey that assessed their usage, motivation for use, and perceived efficacy of the following orthobiologics: leukocyte-rich platelet-rich plasma, leukocyte-poor platelet-rich plasma (PRP-LP), bone marrow aspirate concentrate, amniotic membrane products, adipose-derived mesenchymal stromal cells, and umbilical cord–derived cells. Application of these orthobiologics for the following pathologies was assessed: osteoarthritis, muscle injuries, tendon injuries, ligament injuries, labral injuries, and focal articular cartilage tears. Results: The survey was completed by 165 respondents (27.5%), of which 66.1% reported using at least one orthobiologic in their practice. Orthobiologic users reported the following: 71.6% are increasing their use, and 23.9% advertise their use. PRP-LP is the most commonly used orthobiologic for 76.1%, with 30% of PRP-LP users reporting use due to competitor utilization. The pathology most commonly treated with orthobiologics is osteoarthritis, for 71.6% of users, who primarily use PRP-LP in the knee joint. Leukocyte-rich platelet-rich plasma is the most popular orthobiologic in muscle, ligament, tendon, and labral injuries, whereas bone marrow aspirate concentrate is most popular for focal articular cartilage injuries. Primary orthobiologic-eligible groups were adults and recreational noncompetitive athletes. More than half (>50%) of orthobiologic users perceived all but umbilical cord–derived cells to be efficacious. Conclusion: Orthobiologics are used by a significant number of sports medicine physicians and are likely increasing in popularity. Among orthobiologics, platelet-rich plasmas are the most popular, and osteoarthritis is the pathology most likely to be treated. Orthobiologics are sometimes used for reasons other than clinical efficacy, especially competitor utilization, and physicians are disparate in their application of these products.
BackgroundPerforming elective orthopaedic surgery on patients with high BMI, poorly controlled hyperglycemia, and who use tobacco can lead to serious complications. Some surgeons use cutoffs for BMI, hemoglobin A1c, and cigarette smoking to limit surgery to patients with lower risk profiles rather than engaging in shared decision-making with patients about those factors. Other studies have suggested this practice may discriminate against people of lower income levels and women. However, the extent to which this practice approach is used by orthopaedic surgeons at leading hospitals is unknown.Questions/purposes(1) How often are preoperative cutoffs for hemoglobin A1c and BMI used at the top US orthopaedic institutions? (2) What services are available at the top orthopaedic institutions for weight loss, smoking cessation, and dental care? (3) What proportion of hospital-provided weight loss clinics, smoking cessation programs, and dental care clinics accept Medicaid insurance?MethodsTo investigate preoperative cutoffs for hemoglobin A1c and BMI and patient access to nonorthopaedic specialists at the top orthopaedic hospitals in the United States, we collected data on the top 50 orthopaedic hospitals in the United States as ranked by the 2020 US News and World Report’s “Best Hospitals for Orthopedics” list. We used a surgeon-targeted email survey to ascertain information regarding the use of preoperative cutoffs for hemoglobin A1c and BMI and availability and insurance acceptance policies of weight loss and dental clinics. Surgeons were informed that the survey was designed to assess how their institution manages preoperative risk management. The survey was sent to one practicing arthroplasty surgeon, the chair of the arthroplasty service, or department chair, whenever possible, at the top 50 orthopaedic institutions. Reminder emails were sent periodically to encourage participation from nonresponding institutions. We received survey responses from 70% (35 of 50) of hospitals regarding the use of preoperative hemoglobin A1c and BMI cutoffs. There was no difference in the response rate based on hospital ranking or hospital region. Fewer responses were received regarding the availability and Medicaid acceptance of weight loss and dental clinics. We used a “secret shopper” methodology (defined as when a researcher calls a facility pretending to be a patient seeking care) to gather information from hospitals directly. The use of deception in this study was approved by our institution’s institutional review board. We called the main telephone line at each institution and spoke with the telephone operator at each hospital asking standardized questions regarding the availability of medical or surgical weight loss clinics, smoking cessation programs, and dental clinics. When possible, researchers were referred directly to the relevant departments and asked phone receptionists if the clinic accepted Medicaid. We were able to contact every hospital using the main telephone number. Our first research question was answer...
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.
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