Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PolyPid Ltd.
- 入组人数
- 51
- 试验地点
- 12
- 主要终点
- Safety: Deep Infection in the target fracture site
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Safety: Deep Infection in the target fracture site
时间窗: During the 4 weeks post index procedure
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.
Performance: Radiographic-assessed bone healing
时间窗: During the 24-week follow-up period
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.
次要结局
- Performance: Time to Radiographic-assessed bone healing(During the 24-week follow-up period)