CIDUCT: Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Surgical Planning and 3D Prototyping Techniques

1. Recruitment Patients with a comminuted distal tibia fracture (OTA 43-C type) who present for care at Inova Fairfax Medical Campus (IFMC) or at the Inova Medical Group (IMG) Orthopaedic outpatient clinic will be eligible for consent and possible enrollment in this study. Patients will not be compensated for participating in this study. Given that this is a convenience sample of patients who present with an acute traumatic injury, there are no plans to advertise or recruit patients.
2. Subject Randomization and Blinding Procedures Eligible patients will be randomized in equal proportions to one of two groups (enhanced pre-operative planning vs. SOC pre-operative planning) using an electronic randomization system with a simple randomization table. After consent and inclusion/exclusion criteria have been confirmed, subjects will be randomized by a research coordinator/associate. All surgeons will be temporarily blinded to the randomization assignment, in order to complete an unbiased pre-operative plan (pre-randomization survey) using the SOC imaging alone (plain film radiographs and 3D CT scan). After the pre-operative plan (pre-randomization survey) is completed by the attending surgeon (using the SOC imaging alone) and submitted to the research coordinator/ associate, the surgeon will be informed of the randomization assignment. For subjects randomized to the enhanced pre-operative planning group, the surgeon will then be provided the 3D prototype and be asked to complete a post-randomization survey capturing their pre-operative plan. The biomechanics lab with arrange with the research coordinator/associate for delivery of the 3D prototype, ensuring that the temporary blinding of treatment assignment is not broken. A post-randomization survey will not be administered to surgeons with subjects randomized to the SOC group.

Subjects will not be blinded to the assigned group. However, in order to ensure the temporary blind is maintained with the attending surgeon who will be performing the definitive surgery, the subject won't be informed of their randomization assignment until the time of definitive surgery. 3. Standard of Care Procedures Prior to Definitive Surgery: All Groups The following pre-operative care described is the standard of practice and is a general summary of the care that will be given to all study patients prior to their definitive surgery, regardless of treatment group assignment. There are two scenarios with which patients will be eligible and approached for participation in this study: 1). stable fracture treated with a splint, and 2). unstable (open or closed) fracture requiring external-fixator surgery.

All patients will be initially evaluated in the emergency department (ED) by a member of the orthopaedic trauma team. Patients with an axially stable injury will undergo manual realignment and application of a well-padded posterior with U-shaped plaster splint. A computed tomography (CT) scanning with sagittal, coronal reconstructions and 3D reformations will be obtained in the ED; and then sent home after learning to crutch ambulate, with instructions for continued strict elevation, non-weight bearing, and follow-up in the clinic. Once these patients are seen in the clinic, it is determined that surgery is required and the patient is subsequently scheduled for definitive surgery, to occur after resolution of swelling and normalization of skin.

Patients who present in the ED with axially unstable-closed fractures on initial plain radiographs will undergo closed reduction and be admitted to the hospital for surgical placement of a temporizing, spanning external-fixator (Depuy Synthes Inc. West Chester, PA). Patients with axially unstable-open fractures will be administered intravenous antibiotics and tetanus update on presentation to the ED, and will go to the operating room for urgent initial debridement and placement of a temporizing, spanning external-fixator. Patients with unstable fractures (open or closed) will have computed tomography (CT) scanning with sagittal, coronal reconstructions and 3D reformations after placement of an external-fixator. Patients will be discharged with appropriate placement (home vs. acute rehab vs. SNF) after evaluation by physical therapy and have their definitive surgery scheduled. All patients will be non-weight bearing to the study injury limb. Definitive operative fixation will occur after resolution of swelling and normalization of skin. 4. Study Procedures: Pre-operative Surgery Planning and open treatment and internal fixation (ORIF) Surgery

4.1 Standard of Care In the control group, 20 patients will have standard of care treatment, which includes pre-operative evaluation and surgical planning based on plain films (3 views: anterior, lateral and oblique) and CT scans with sagittal, coronal and 3D reformations. Operative fixation of the fractures using distal tibia fracture fixation implants (Depuy Synthes Inc. West Chester, PA) will be performed through standard approaches as judged by the operating surgeon. The implants can include, but is not limited to: 3.5 mm LCP Low Bend Medial Distal Tibia Plates, 3.5 mm LCP Antero-lateral Distal Tibia Plates, 3.5 mm LCP Posterior Distal Tibia Plates, or 2.7 mm / 3.5 mm LCP Distal Fibula Plates.