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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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