Injury, Occupational Diseases, Poisoning Surgery Orthopaedics
Conditions
Interventions
AEFIX external fixation system
Locally available external fixation
Sponsors
Harvard Global Orthopaedics Collaborative
SONA Global
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 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. 4. A participating surgeon or delegate at a study site will perform all planned surgeries (i.e. there is no pre-operative plan for the patient to be transferred into another facility/surgeon’s care after external fixation is performed). 5. Informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with established fracture malunions or nonunions, including any patient undergoing correction of deformity, management of a malunion, nonunion, or delayed union. 2. Patients with established chronic osteomyelitis or pathologic fractures. 3. Patients undergoing limb deformity correction or bone transport. 4. Patients with periprosthetic fractures. 5. Patient incarceration. 6. Patients currently enrolled in another study that does not permit co-enrollment. 7. Unable to obtain informed consent due to language barriers. 8. Prior enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maintenance of fracture reduction as measured on initial post-operative and subsequent radiographs after application of external fixation until removal. X-rays will be taken within 24 hours after the initial surgery during which external fixation, either AEFIX or the locally available devices, would have been applied by the treating surgeon. X-rays will be repeated a maximum of 48 hours prior to removal of the external fixator construct, with or without conversion to internal fixation. Any x-rays taken between external fixator application and removal shall also be recorded in the electronic data collection system. Fracture reduction will be compared between the initial and subsequent x-rays. Fracture alignment and angulation, and any fracture gap will be measured and compared between x-rays. The degree of fracture displacement shall be compared between the treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of clinical complications (pin tract infections, superficial/deep infection, iatrogenic neurovascular injuries, malunion/nonunion, amputation, death);Quality of life and functional recovery as measured by the EQ-5D instrument ;Clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument | — |
Countries
Rwanda
Contacts
Public ContactKiran Agarwal Harding
Assistant Professor Harvard Medical School
Outcome results
None listed