Status:
TERMINATED
Carbon Fiber Implants
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
CarboFix Orthopedics
Conditions:
Tibial Shaft Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
The tibia (long bone in the leg) bears most of the body weight and is the most commonly fractured long bone in the body. According to the National Center for Health Statistics; tibia, fibula and ankle...
Eligibility Criteria
Inclusion
- 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
- 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 challenged or has a severe psychiatric condition xi. Patient is incompetent in the English Language xii. Patient is non-ambulatory before injury or as a consequence of polytrauma xiii. Inability to obtain patient's informed consent and/or that of a legally acceptable representative
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Key Trial Info
Start Date :
May 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03382041
Start Date
May 23 2017
End Date
March 31 2021
Last Update
July 25 2023
Active Locations (1)
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1
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233