The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* i. Skeletal maturity (patients included will be 18 - 64 years, i.e. whose epiphyseal/growth plates are closed) ii. Arbeitsgemeinschaft ur Osteosynthesefragen/Orthpaedica Trauma Association (AO/OTA) Fracture class 42; open and closed tibia shaft fracture (Gustilo-Anderson Types I II, and III; Tscherne closed types 0, I, 2 and 3), Tscherne open types I and II.
iii. Fractures amenable to intramedullary nailing (placing a rod within the bone) iv. Fracture gaps less than 2 cm due to bone loss v. In cases of bilateral tibial fractures the investigators would include both if they meet inclusion criteria..
vi. Patient's informed consent or that of a legally acceptable representative
Exclusion Criteria:
i. Subjects currently enrolled in one or more clinical studies ii. Skeletal immaturity (i.e. 17 years and younger) iii. Fractures planned for non-operative management iv. Complex intra-articular involvement of tibia plateau or distal tibia v. Pathologic fractures (fractures secondary to disease) vi. Concomitant ipsilateral tibia shaft fractures with complex pilon and/or plateau fractures requiring fixation vii. Patients already treated or in re-treatment viii. Tibia already infected as diagnosed by the attending physician ix. Patients likely to be lost before completing adequate follow-up, such as prisoners or planned out-of-state (and other likely problems in the investigator's judgment, with maintaining follow-up visit schedule) x. Patient is intellectually…
What they're measuring
1
The Number of Participants Identified With Fracture Healing
Timeframe: From baseline through 6 weeks.
2
The Number of Participants Identified With Fracture Healing