High-Level Clinical Research in Developing Countries? Yes!
Generally speaking, orthopaedic surgeons in low-resourced environments deliver the best care for their patients with skill, creativity, and passion. These surgeons are accustomed to scrambling for implants and other tools and to working around limited access to operating theaters and anesthesia services. Their everyday struggles usually leave little energy or time to even think about clinical research.
However, in the May 20, 2020 issue of The Journal, Haonga and colleagues prove that, with a “little help from their friends,” it is possible to conduct Level I research while treating patients in a resource-limited setting. They enrolled and followed 221 patients with open tibial fractures (mostly males in their 30s injured in a road-traffic collision) and randomized them to treatment with either uniplanar external fixation or intramedullary (IM) nailing. The nails were supplied by SIGN Fracture Care International, a not-for-profit humanitarian organization that provides specially designed IM nails that can be used without image intensification to hospitals in developing countries around the world. (See related OrthoBuzz post.)
The research was done in Dar es Salaam, Tanzania, in collaboration with trauma surgeons and epidemiologists from the University of California San Francisco, which has a long-standing relationship with Tanzania’s Muhimbili National Hospital. At the 1-year follow-up, there were no significant between-group differences in primary-outcome events—death or reoperation due to deep infection, nonunion, or malalignment. IM nailing was associated with a lower risk of coronal or sagittal malalignment, and quality-of-life (QoL) scores favored IM nailing at 6 weeks, but QoL differences dissipated by 1 year.
Just as important as the clinical findings, these investigators proved that it is possible to do high-level research in centers with high patient volume and limited resources. Future patients will benefit because the clinicians now have better information to share regarding expectations for functional recovery and risk of infection. Physicians and other healthcare professionals benefit because data like this help improve their analytical skills and become more discerning appraisers of the published literature. With strong internal physician leadership and a little outside support, Haonga et al. have convinced us that prospective—and even randomized—research is possible in these special places.
Finally, SIGN deserves our support as a true champion of orthopaedic surgeons working in under-resourced environments. In addition to providing education and implants, SIGN surgeons are required to report their cases through the SIGN Surgical Database—which encourages the research mindset and helps SIGN surgeons improve tools and techniques for better patient outcomes.
Marc Swiontkowski, MD