Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Be'er Sheva', 이스라엘
- Soroka Medical Center
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Haifa, 이스라엘, 31096
- Rambam Health Care Campus
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Jerusalem, 이스라엘
- Hadassah University Hospital
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Tel Aviv, 이스라엘, 64239
- The Tel Aviv Sourasky Medical Center
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Tel Hashomer, 이스라엘, 5262100
- The Chaim Sheba Medical Center
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Merkaz
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Petah Tiqva, Merkaz, 이스라엘
- Rabin Medical Center
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Cavite, 필리핀 제도
- De La Salle HSI
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Manila City, 필리핀 제도
- Philippines General Hospital
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Quezon City, 필리핀 제도
- Philippine Orthopedic Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or non-pregnant female aged between 18 to 70 years of age.
- 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.
- 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.
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.
- 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:
- Female who is pregnant or breastfeeding.
- 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.
- Subjects with fractures due to known medical history of Osteoporosis.
- Subject with known medical history of Diabetes.
- Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
- Drug/alcohol abusers
- Acute infection in another sites/organs.
- Non-ambulating subjects prior to the trauma.
- More than 24 hours between injury and systemic antibiotic treatment initiation
- Subjects with bone fracture due to known medical history of metabolic bone diseases.
- Subjects with high velocity gunshot bone fractures.
- Subjects with major intra-articular fractures
- Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
- Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
- Previous surgical intervention in the target tibia
- Subject with previous open fractures within one year in the target tibia
- Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: BonyPid-1000
Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC)
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BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Standard of Care (SOC) treatment only
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다른: Study control arm
Standard of care treatment (SOC) only
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Standard of Care (SOC) treatment only
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety: Deep Infection in the target fracture site
기간: During the 4 weeks post index procedure
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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.
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During the 4 weeks post index procedure
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Performance: Radiographic-assessed bone healing
기간: During the 24-week follow-up period
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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.
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During the 24-week follow-up period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Performance: Time to Radiographic-assessed bone healing
기간: During the 24-week follow-up period
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Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
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During the 24-week follow-up period
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Shany Blum, Dr., PolyPid Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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