This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the EVOS SMALL Plating System in subjects with proximal or distal (pilon or ankle) tibial fractures. Subjects will be recruited in the hospital emergency room or surgical department, at the point of identification of the need for ORIF surgery, and the decision is made to use the EVOS SMALL Plating System. The choice of medical and surgical treatment will be made independently by the Investigator in the regular course of practice and will not be influenced by this study protocol. Approximately 100 subjects will be enrolled in order to ensure at least 90 evaluable subjects, with a minimum of 45 evaluable subjects having either a) proximal or b) distal tibial fractures. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative fracture resolution according to standard radiological practice (X-rays), clinical complications, reoperation rate, DRI, EQ-5D-5L, and pain VAS.
Study Type
OBSERVATIONAL
Enrollment
2
Athens Orthopedic Clinic
Athens, Georgia, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System
Time frame: 1 year
Number of adverse events
Time frame: 1 year
Disability Rating Index (DRI)
Change in subject's ease of mobility as marked on a 100 mm line by subject with the far left indicating "without difficulty" and the far right indicating "not at all"
Time frame: 1 year
EuroQoL-5D Questionnaire
Change in quality of life from baseline to one year postoperatively by answering quality of life questions on a 1-5 scale with 1 representing "never" and 5 representing "always"
Time frame: 1 year
Pain using visual analog scale (VAS)
level of pain as marked on a 100 mm line by subject with 0mm representing "no pain" and 100mm representing "worst possible pain"
Time frame: 1 year
Number of complications relating to surgery
Time frame: 1 year
Number of hospital readmissions for any reason
Time frame: 1 year
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