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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02491047 |
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Date of registration:
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02/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
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Scientific title:
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Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02491047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Philippines
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Contacts
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Name:
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Shany Blum, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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PolyPid Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tibial Fractures
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Open Fractures
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Intervention(s)
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Device: BonyPid-1000
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Other: Standard of Care (SOC) treatment
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Primary Outcome(s)
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Safety: Deep Infection in the target fracture site
[Time Frame: During the 4 weeks post index procedure]
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Performance: Radiographic-assessed bone healing
[Time Frame: During the 24-week follow-up period]
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Secondary Outcome(s)
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Performance: Time to Radiographic-assessed bone healing
[Time Frame: During the 24-week follow-up period]
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Secondary ID(s)
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BonyPid-1000TM-103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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