Clinical Research at the Institute for Global Orthopaedics and Traumatology
The IGOT Global Research Initiative (GRI) seeks to improve research capacity in low- and middle-income countries through academic partnership. Led by Saam Morshed, MD, MPH, PhD and David Shearer, MD, MPH, the GRI is among the leading centers in the country actively conducting prospective research in the field of orthopaedic surgery in low-resource settings. Our principal partners include academic centers in Tanzania, Malawi, Uganda, Ghana, and Latin America.
Current IGOT Research Projects:
Tanzania- Intramedullary Nailing Versus External Fixation for Open Tibia Fractures Randomized Controlled Trial Long-Term Follow-Up
- Open tibia fractures are among the most common and debilitating injuries faced in low-income countries due to high rates of infection and nonunion. This study aims to address the question of whether internal or external fixation is better as definitive treatment for open tibia fractures in Tanzania. The study has enrolled and randomized 240 patients and achieved greater than 90% 1 year follow up. The study is currently conducting final data analysis, and we anticipate publication in the near future.
Tanzania- Cost-effectiveness of Prosthetics for Above Knee Amputees
- Many amputees in low-income countries do not receive a prosthesis due to the high cost and failure of most governments to fund prosthetic programs. As a result, they suffer from severe disability and are limited to use of crutches or a wheelchair in most cases. In collaboration with Legworks, a local prosthetics company (www.Legworks.com), IGOT is conducting a prospective study to assess the cost and benefit of a prosthesis for above knee amputees. We believe these data will create a compelling case to advocate for better access to prosthetics in low-resource settings like Tanzania
Tanzania - Low-cost Intramedullary K-wires for Pediatric Femur Fractures
- Femoral shaft fractures in children are commonly treated with surgery using flexible nails to avoid damage to growth plates. However, titanium flexible nails that are commonly used in high-income countries are cost-prohibitive for many families in low-income countries where governments do not subsidize implant costs. Substituting titanium flexible nails with stainless steel “Kirschner wires” could reduce the cost of these implants nearly 40-fold, thereby markedly increasing access to surgery for children globally. IGOT is supporting a randomized controlled trial in Tanzania comparing these low-cost implants to the high-cost titanium nails for children with femoral shaft fractures.
Tanzania - A Pilot Masked, Randomized Controlled Trial Evaluating Locally applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia)
- Tibial shaft fractures are the most common long-bone fracture. Deep infection remains a common, devastating complication of open injuries leading to lifelong impairment that disproportionately affects low- and middle-income countries (LMICs). Thorough surgical debridement, followed by fracture stabilization using internal or external fixation, is the mainstay of treatment. One proposed adjunctive measure is prophylactic local antibiotic delivery, which can achieve much higher antibiotic concentrations at the surgical site than can be achieved safely with systemic administration. There is a growing body of literature evaluating local antibiotic administration in both aqueous and powder form at the time of wound closure. While demonstrating potentially promising results, these studies are heterogeneous, of poor general methodologic quality, and none originate from LMICs where this technique would have the greatest potential benefits. Local gentamicin is particularly promising given the broad spectrum of activity against common pathogens in osteomyelitis (staphylococcus, gram-negative rods), wide availability, and low cost (<1$ per 80mg vial). IGOT propose a prospective, blinded, randomized controlled trial enrolling adult open tibial shaft fractures at the Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. At the time of initial debridement, participants will be randomly assigned to receive aqueous gentamicin after closure or placebo saline injection. The primary outcome will be deep surgical site infection at 1 year. Secondary outcomes include health-related quality-of-life (HRQOL), modified Radiographic Union Scale for Tibial Fractures (mRUST), FIX-IT score for clinical healing, and cost of treatment using time-driven activity-based costing (TDABC) and survey methods.
Tanzania – Total Joint Replacement Registry
- Our partners at Muhimbili Orthopaedic Institute in Tanzania created an excel sheet registry ten years ago with 900+ patients. This project will use this excel sheet to create and implement a formal registry prospectively using REDCap for total joint replacement procedures at Muhimbili Orthopaedic Institute. The aim of this project is to formalize and optimize the current system in collaboration with the local physicians.
Ghana – Predictors of Quality of Life and Economic Impact after Open Tibia Fractures
- This study is led by our resident PGY4, Heather Roberts, under the mentorship from Drs. Saam Morshed and Dave Shearer.
This is a prospective study of open tibia fracture management in Kumasi, Ghana. The purpose of this study is to examine the influence of socioeconomic status on type of treatment for open tibia fractures, and in turn the influence of type of treatment on clinical and economic impact after open tibia fractures. The results of this study will impact policies that support investment in surgical care and inform evidence-based protocols in low-resourced settings where the burden of orthopedic trauma is highest.
Malawi- Intramedullary Nailing Versus Skeletal Traction for Femoral Shaft Fractures
- IGOT is working in collaboration with investigators at Beit CURE Hospital in Blantyre, Malawi to conduct a prospective multicenter study comparing quality of life and cost-effectiveness of surgery versus skeletal traction for adult femoral shaft fractures. The study has enrolled more than 200 patients and achieved a follow up rate at 1 year of nearly 90%, which is unprecedented. The study is anticipated to complete final follow up in the Summer of 2019. This will be the largest and most rigorous study comparing surgical and non-operative treatment for femoral shaft fractures ever conducted.
Uganda- Post Injection Risk and Gluteal Fibrosis Study
- Coleen Sabatini, MD, MPH leader of IGOT’s pediatric outreach efforts, has developed a robust partnership in Uganda exploring the surgical outcomes of children treated for gluteal fibrosis, along with a qualitative study on injection practices. The qualitative study on injection practices currently has 60 interviews completed and submitted an article to be published. A third study is also being conducted regarding treatment of intra-articular and extra- articular distal femoral fractures using SIGN nail at Kumi Orthopaedic Center. This study has completed data collection and analysis and found 48% f/u at 16 weeks.
Latin America - ACTUAR Open Tibia Study
- Theodore Miclau, MD, Vice Chairman and Director of Orthopaedic Trauma of the Department of Orthopaedic Surgery at UCSF, fostered our international partnerships in Latin America. There is need for global North American-South American relationships that allow South American colleagues to access resources available in North American centers, which include expertise, organization, and infrastructure, to address research questions relevant to the South American countries. To this end, the Asociación de Cirujanos Traumatológicos en las Americas (ACTUAR) was developed. ACTUAR, led by organizing faculty from UCSF/IGOT, is the product of a group of orthopaedic surgeons interested in an international collaborative initiative focused on building research capacity across institutions throughout Latin America. The consortium is currently in the process of planning a prospective multicenter study to examine the state of care and predictors of quality of life after open tibial shaft fractures in Latin America.
IGOT Global Research Initiative team has been active in publishing several intriguing articles, check out few of the recent publications!
• Von Kaeppler E, Donnelley C, Roberts HJ, O’Hara NN, Won N, Shearer DW, Morshed S. Impact of North American Institutions on Orthopedic Research in Low-and Middle-Income Countries. Orthop Clin N Am. 2020; 51:177–188.
• Haonga BT, Liu M, Albright P, Challa ST, Ali SH, Lazar AA, Eliezer EN, Shearer DW, Morshed S. Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibial Fractures in Tanzania: Results of a Randomized Clinical Trial. J Bone Joint Surg Am. 2020 Feb 5.
• Ali SH, Albright P, Morshed S, Gosselin RA, Shearer DW. Orthopaedic Trauma in Low-resource Settings: Measuring Value. J Orthop Trauma. 2019 Nov;33 Suppl 7:S11-S15.
• Chokotho L, Lau BC, Conway D, Wu HH, Shearer D, Hallan G, Gjertsen JE, Mkandawire N, Young S. Validation of Chichewa Short Musculoskeletal Function Assessment (SMFA) questionnaire: A cross-sectional study. Malawi Med J. 2019 Mar;31(1):65-70.
• Conway D, Albright P, Eliezer E, Haonga B, Morshed S, Shearer DW. The burden of femoral shaft fractures in Tanzania. Injury. 2019 Jul;50(7):1371-1375.
• Curran PF, Albright P, Ibrahim JM, Ali SH, Shearer DW, Sabatini CS. Practice Patterns for Management of Pediatric Femur Fractures in Low- and Middle-Income Countries. J Pediatr Orthop. 2019 Aug 14.
• Holler JT, Albright P, Challa S, Ali SH, Martins D, Keys K, Shearer DW, Terry MJ. Barriers to Performing Soft Tissue Reconstruction Procedures among Orthopedic Surgeons in Low- and Middle-income Countries: Results of a Surgical Skills Training Course. Plast Reconstr Surg Glob Open. 2019 Oct 29;7(10):e2420.
• Haonga BT, Areu MMM, Challa ST, Liu MB, Elieza E, Morshed S, Shearer D. 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. SICOT J. 2019;5:20.
• Ibrahim JM, Liu M, Wu HH, Patel KR, Caldwell AM, Coughlin RR, Morshed S, Shearer DW. The extent of pediatric orthopaedic research in low- and middle-income countries and the impact of academic collaboration on research quality: a scoping review. Pediatr Surg Int. 2019 Mar;35(3):397-411.
• Ley P, Gosselin RA, Villar R. The Masquelet induced-membrane technique: an option for a tertiary-referral conflict setting. J Surg Case Rep. 2019 Jun 28;2019(6):rjz149. doi: 10.1093/jscr/rjz149. eCollection 2019 Jun. Erratum in: J Surg Case Rep. 2019 Jul 11;2019(7)
• Liu MB, Ali SH. Surgical Implant Generation Network (SIGN) Fin Nail versus SIGN Standard Intramedullary Nail for Distal Diaphyseal Femur Fractures Treated via Retrograde Approach. Injury. 2019 Sept.
• Wu HH, Liu M, Challa ST, Morshed S, Eliezer EN, Haonga BT, Zirkle L, Shearer DW. Development of Squat-and-Smile Test as Proxy for Femoral Shaft Fracture- Healing in Patients in Dar es Salaam, Tanzania. Journal of Bone & Joint Surgery. 2019 Feb; 101 (4): 353.