Rajendra Surenthirakumaran1, Lie Tijauw Tjoen Denny2,3, Kiran Jay Agarwal-Harding4,5, Kizher Shajahan Mohamed Buhary2,3, Alexis Thayaparan Christine Thevamirtha1, Paskaran Pirasanth1, Ajeetha Jeevarajan1, Sinnathurai Majooran6, Paramalingam Srigrishna7, Sivananthan Sashikaran7, Thayasivam Gobyshanger7, Muhammad Daniel Azlan bin Mahadzir8,9, Jonas Karlström8, Sreekanthan Gobishangar1
1Faculty of Medicine, University of Jaffna, Jaffna, Sri Lanka;
2Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore;
3SingHealth Duke-NUS Musculoskeletal Sciences Academic Clinical Programme, Duke-NUS Medical School, Singapore, Singapore;
4Harvard Global Orthopaedics Collaborative, Boston, MA, USA;
5Carl J. Shapiro Department of Orthopaedics, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA;
6District General Hospital, Vavuniya, Sri Lanka,7Teaching Hospital, Jaffna, Sri Lanka;
8SingHealth Duke-NUS Global Health Institute, Duke-NUS Medical School, Singapore, Singapore;
9SingHealth Office for Sustainable Health, Singapore, Singapore
Background: Sri Lanka faces over 38,000 road accidents annually, causing more than 8,000 serious injuries, especially open fractures needing external fixation. Delayed care can result in disability, amputation, or death. Access remains limited due to the high cost, clamps alone make up 90% of system costs, and shortages of surgical personnel. AEFIX clamps offer a breakthrough: made entirely of aluminum, they provide a durable, functional alternative at just 1% of the standard external fixation price. This study aims to assess the safety, effectiveness, and patient outcomes of the AEFIX external fixator compared to locally available devices in Northern Province, Sri Lanka.
Methods: A prospective multicenter randomized non-inferiority trial began in May 2025 and will run for one year at orthopedic units in Northern Sri Lanka. Fifty patients with open femur and/or tibia fractures will be recruited and randomized to receive AEFIX fixators or standard external fixators. Ethical approval (J/ERC/24/157/NDR/0317), National Medicines Regulatory Approval (CTM/046/2025), and Sri Lanka Clinical Trial registration (SLCTR/2025/018) have been obtained. Patients will be followed during admission and at 1.5-, 3-, and 6-month post-procedure.
Results: Preliminary results from the first group of recruited patients (n=5) indicate that the device performs well in this clinical setting. Post-operative X-ray examination confirmed improved fracture alignment, and there were positive signs in healing and low complication rates up to this point. Preliminary results with low-cost AEFIX clamps are promising. This trial will assess outcomes and costs of AEFIX, supporting broader efforts to improve trauma care in low-resource settings.
Conclusions: Sri Lanka faces a high burden of complex fractures from road traffic injuries. This study is a warranted step toward expanding access to affordable, high-quality external fixation options. This project is supported by the SingHealth Duke-NUS Musculoskeletal Science Academic Clinical Programme Grant Award (13/FY2023/P2/13-A153).
Keywords: Global surgery; frugal innovation; open tibia fracture; orthopedic; health equity
