Tibial Fractures Clinical Trial
Official title:
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study. This study will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.
The study population include subjects with a classification of Gustilo I, II, IIIA or IIIB of
tibial open fractures, assigned for surgical procedure, who meet eligibility criteria and
provide signed informed consent.
Subjects will be randomized into either Study investigational arm or Study control arm, using
a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ;
IIIB).
Total duration of the study is expected to be approximately 32 months from first subject
enrolled until last subject completed.
It is expected that each subject will be in the study for approximately 52 weeks
Subjects will be followed at the following time points:
- Immediately post index procedure
- During hospitalization
- Discharge visit
- 4 weeks and then monthly up to 24 weeks, 36 and at 52 weeks.
This is a single blind clinical trial. Subjects and their family members will be blinded to
the treatment arms assignment. The study site personnel present at the baseline procedure as
well as the physician performing the procedure will be trained not to disclose the treatment
arm to the subject, his/her family, and to health care providers outside of the Orthopedic
department.
An independent X-ray reading center assessing all subjects' images will be blinded to the
treatment arms assignments, for the entire trial period. However, due to the radiographic
appearance of the BonyPid-1000 as compared to SOC may differ, it is not entirely possible to
blind the evaluating radiologists.
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