John Ibrahim1, Max Liu2, Kurt Yusi1, Billy Haonga3, Edmund Eliezer3, David W Shearer1, Saam Morshed1,4. 1. Orthopaedic Trauma Institute, Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA. 2. Department of Orthopaedic Surgery, Stanford University, Redwood City, CA. 3. Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania. 4. Department of Epidemiology and Biostatistics, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA.
Abstract
INTRODUCTION:Low- and middle-income countries (LMICs) experience a large volume of orthopaedic trauma, but limited research exists to evaluate effective treatments using locally available means. Academic partners can help design and implement research studies through collaborative efforts with local investigators. We will describe the study design and lessons learned from a randomized controlled trial in Tanzania comparing outcomes of 2 operative treatments for open tibia fractures. STUDY DESIGN: The Institute for Global Orthopaedics and Traumatology at the University of California, San Francisco, and the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, partnered to design a prospective, randomized controlled trial. Adult patients with open tibia fractures were randomized to receive either intramedullary nailing or external fixation as definitive fixation. Our primary outcome was the rate of reoperation, and secondary outcomes included EQ-5D, pain, function, radiographic union, and return to work. RESULTS: We enrolled 40 patients in a pilot study that informed improvements in the study design and standard operating procedures. These modifications included development of a specific outline of the technical standards for each surgical intervention and held training workshops to disseminate this knowledge among operative surgeons. This resulted in the successful enrollment and standardized treatment of our target sample of 240 patients. DISCUSSION: There are several challenges in conducting high-quality, international research. Keys for success include maintaining a strong relationship between partners, having local research coordinators, simplifying data collection and storage, and incentivizing patients to attend follow-up visits.
RCT Entities:
INTRODUCTION: Low- and middle-income countries (LMICs) experience a large volume of orthopaedic trauma, but limited research exists to evaluate effective treatments using locally available means. Academic partners can help design and implement research studies through collaborative efforts with local investigators. We will describe the study design and lessons learned from a randomized controlled trial in Tanzania comparing outcomes of 2 operative treatments for open tibia fractures. STUDY DESIGN: The Institute for Global Orthopaedics and Traumatology at the University of California, San Francisco, and the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, partnered to design a prospective, randomized controlled trial. Adult patients with open tibia fractures were randomized to receive either intramedullary nailing or external fixation as definitive fixation. Our primary outcome was the rate of reoperation, and secondary outcomes included EQ-5D, pain, function, radiographic union, and return to work. RESULTS: We enrolled 40 patients in a pilot study that informed improvements in the study design and standard operating procedures. These modifications included development of a specific outline of the technical standards for each surgical intervention and held training workshops to disseminate this knowledge among operative surgeons. This resulted in the successful enrollment and standardized treatment of our target sample of 240 patients. DISCUSSION: There are several challenges in conducting high-quality, international research. Keys for success include maintaining a strong relationship between partners, having local research coordinators, simplifying data collection and storage, and incentivizing patients to attend follow-up visits.
Authors: Billy T Haonga; Max Liu; Patrick Albright; Sravya T Challa; Syed H Ali; Ann A Lazar; Edmund N Eliezer; David W Shearer; Saam Morshed Journal: J Bone Joint Surg Am Date: 2020-05-20 Impact factor: 6.558
Authors: Joseph T Patterson; Patrick D Albright; J Hunter Jackson; Edmund N Eliezer; Billy T Haonga; Saam Morshed; David W Shearer Journal: OTA Int Date: 2020-03-03
Authors: Alexander Coburn; David Shearer; Patrick Albright; Syed Ali; Heather J Roberts; Billy Haonga; Edmund Eliezer; Kevin Chu; Saam Morshed Journal: OTA Int Date: 2020-12-23