Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures

Launched by POLYPID LTD. · Jul 6, 2015

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant female aged between 18 to 70 years of age.
• • 2. Female of childbearing potential should have a negative urine pregnancy test prior to index procedure Note: All female of childbearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
• • 3. Subjects with tibia open fractures of Gustilo grade I, II, IIIA or IIIB, who are assigned for surgery and are suitable for bone filler implantation, are eligible to participate in the study.
• • 4. Single or multi-injured subjects who are hemodynamically and physiologically stable.
• • Note: A multi-injured subject is defined as one who sustains ≥2 injuries, each injury requiring hospitalization, independently of the presence of other injuries.
• • 5. Subjects who are able and willing to sign an informed consent form, prior to any protocol-specific procedures being performed and accept to comply with protocol requirements for the duration of the study. In specific cases, due to medical condition (e.g. a medical condition which necessitate an immediate medical treatment), a shortened consenting process may take place in accordance with local regulations.
• Exclusion Criteria:
• • 1. Female who is pregnant or breastfeeding.
• • 2. Subjects with known current disseminated malignancies, active cancer or autoimmune diseases. Note: active cancer defined as - cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment.
• • 3. Subjects with fractures due to known medical history of Osteoporosis.
• • 4. Subject with known medical history of Diabetes.
• • 5. Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
• • 6. Drug/alcohol abusers
• • 7. Acute infection in another sites/organs.
• • 8. Non-ambulating subjects prior to the trauma.
• • 9. More than 24 hours between injury and systemic antibiotic treatment initiation
• • 10. Subjects with bone fracture due to known medical history of metabolic bone diseases.
• • 11. Subjects with high velocity gunshot bone fractures.
• • 12. Subjects with major intra-articular fractures
• • 13. Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
• • 14. Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
• • 15. Previous surgical intervention in the target tibia
• • 16. Subject with previous open fractures within one year in the target tibia
• • 17. Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.