Study of the Osteoconductive Potential of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) in the Filling of Orthopaedic Bone Defects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Successful bone defect reconstruction in the extremities
研究概览
简要总结
Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery
详细描述
The In'Oss™ (MBCP® Putty) device is an Injectable Bone Substitute (IBS) whose purpose is a bone gap and void filler. It forms a putty-like synthetic bone graft which molds to the shape of the defect. It is composed of Hydroxyapatite (HA), Beta Tricalcium Phosphate (ß-TCP) and a hydrogel and is presented in sterile syringes.
The Injectable Bone Substitute In'Oss™ is intended for use to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis). The performances of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process).
The purpose of this study is primarily to collect Post-Market Clinical Follow-up (PMCF) data on the performance and safety of the CE marked In'Oss™ device in the orthopaedic application. The data and conclusions obtained from this study by the Sponsor Advanced Medical Solutions Ltd. (AMS) together with the manufacturer Biomatlante will be used to provide clinical evidence for the clinical evaluation process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or female, 18 - 85 years old;
- •Patient is willing and able to give written informed consent;
- •Patient is able to comply with a prior medical examination;
- •Patient is or has been scheduled for a surgical procedure to correct epiphyso-metaphyseal and/or metaphyso-diaphyseal bone defect in one of the following anatomical locations:
- •Proximal humerus ▪ Distal radius
- •Distal femur ▪ Proximal tibia ▪ Distal tibia
- •Patient is willing and able to comply with the study procedures during surgery and the post-surgical follow up period, up to 12 months.
排除标准
- •Patient has had an infection in the same extremity within last 24 months;
- •Patient has signs of necrosis at the surgical site;
- •Patient has cellulitis;
- •Patient has granuloma or non-curetted cyst;
- •Patient has an history of uncontrolled diabetes;
- •Patient is alcoholic and/or heavy smoker (> 20 cigarettes per day);
- •Patient has a congenital or acquired immunodeficiency;
- •Patient has severe bone loss (≥ 40cm3);
- •Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism;
- •Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device;
- •Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created;
- •Patient was exposed to any radiation (e.g. X-Rays, handling of radiolabelled materials) other than the normal background radiation within the 12 months before the screening visit;
- •Patient is pregnant;
- •Patient who is an employee at the study site;
- •Patient is known to be non-compliant with medical treatment or follow-up
- •Patient has any significant or unstable medical/psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study;
- •Patient is currently enrolled or planning to enrol in another clinical study or treatment with another investigational drug/device that may interfere with the assessments, visits or outcomes of this study.
结局指标
主要结局
Successful bone defect reconstruction in the extremities
时间窗: At 12 months post-surgery
Evaluation of performance of the In'Oss™ (MBCP® Putty) through the achievement of successful bone fusion through radiological evaluation (X-Ray) within 12 months by assessing interdigitation in 3 out of 4 planes (anterior/posterior/lateral/medial).
次要结局
- Evaluation of safety of In'Oss(Within 12 months post-surgery)
- Evaluation of functional mobility restoration in the upper limb with PRO measures(Within 12 months post-surgery)
- Evaluation of functional mobility restoration in the lower limb with PRO measure(Within 12 months post-surgery)
- Evaluation of patient's pain intensity with VAS pain scale(Within 12 months post-surgery)
- Evaluation of device usability(Within 12 months post-surgery)