Is the novel, affordable fracture external fixation system (AEFIX) safe and effective compared to locally available standard care in patients with femur or tibia fractures from the Northern Province of Sri Lanka?

Study Setting: The study will take place at three clinical sites in the Northern Province of Sri Lanka, including Teaching Hospital, Jaffna, District General Hospital Vavuniya, and District General Hospital Kilinochchi.

Method of randomization: Each participant will be randomized using a centralized randomization system, built into the electronic data capture (EDC) system accessed via an internet-enabled device, and available 24 hours per day. The ratio of randomization is 1:1.

1. Investigational Medical Devices (IMDs):

   • AEFIX Set: Each clinical site will be provided with an AEFIX set, including AEFIX clamps, connecting rods, Schanz pins, and accessory supplies. The AEFIX system is manufactured by SONA Global and is classified as Class II by the US FDA. Schanz pins and rods are sourced from CE-certified manufacturers.

2. AEFIX (Intervention):

   • Procedure: Participants randomized to receive the AEFIX system will undergo fracture external fixation using AEFIX clamps. Schanz pins will be placed into the patient’s bone and connected to the connecting rods using AEFIX clamps. The fracture will be reduced, and the clamps fully tightened.

• Usage and Documentation: AEFIX clamps, pins, and rods are designed for single use only. The number of AEFIX components used will be documented and replenished as needed.

1. Locally Available Alternatives (Control):

   • Procedure: Participants randomized to receive external fixation with the locally available system will undergo a similar procedure as with AEFIX. The control groups will use AO type fixator, and the brand and type of the locally available fixator will be documented, including whether the components have been previously used and reprocessed.

2. Discontinuation of Interventions:

   • Safety Concerns: Treatment intervention must be permanently discontinued if a participant experiences any medical condition that jeopardizes their safety. The primary reason for discontinuation should be documented.

   -Duration of External Fixation: The external fixation system (AEFIX or locally available devices) will remain in place until removed by the treating surgeon(s) based on their judgment. Timing and rationale for removal, method of wound management, and timing/method of definitive wound closure will be documented.

1. Males and females 18 years of age or older.

2. Closed or open fractures of the femur and/or tibia, including fractures of the proximal femur, femoral diaphysis, extra-articular and intra-articular fractures of the distal femur and proximal tibia, tibia diaphysis, and extra-articular and intra-articular fractures of the distal tibia including pilon and ankle fractures.

3. Fractures not amenable to internal fixation due to risk of infection, inadequate soft tissue coverage, severe soft tissue trauma, or patient hemodynamic instability, and therefore indicated for external fixation by the treating surgeon (participating surgeon or delegate at a study site will perform all planned surgeries).

1. Patients with established fracture malunions or nonunion.

2. Patients with established chronic osteomyelitis or pathologic fractures.

3. Patients undergoing limb deformity correction or bone transport.

4. Patients with periprosthetic fractures.

5. Medical or injury contraindication to external fixation, for example severe immunocompromised state in which risk of pin tract infection outweighs the benefit of external fixation, in the context of a patient’s specific presentation and history.

6. Patient incarceration.

7. Patients currently enrolled in a study that does not permit co-enrollment.

8. Unable to obtain informed consent due to language barriers.

9. Anticipated problems with maintaining follow-up with the patient, including for eventual external fixation removal, and compliance with pin site care, in the judgement of research personnel.

10. Prior enrollment in the study when considering a new fracture.