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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
51
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Standard of Care (SOC) treatment only
Rabin Medical Center
Petah Tikva, Central District, Israel
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Hadassah University Hospital
Jerusalem, Israel
Safety: Deep Infection in the target fracture site
Deep Infection in the target fracture site during the 4 weeks post index procedure. The endpoint will be assessed by calculating the rate /percent per group.
Time frame: During the 4 weeks post index procedure
Performance: Radiographic-assessed bone healing
Radiographic-assessed bone healing during the 24-week follow-up period, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
Time frame: During the 24-week follow-up period
Performance: Time to Radiographic-assessed bone healing
Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
Time frame: During the 24-week follow-up period
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The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
De La Salle HSI
Cavite, Philippines
Philippines General Hospital
Manila, Philippines
Philippine Orthopedic Center
Quezon City, Philippines