Randomised Investigation of the Osteoconductive Performance and Safety of FDBS Bone Graft, With Contextual Reference to IBS, 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
- 200
- 主要终点
- Evaluation of performance and safety of FDBS and IBS in the reconstruction of bone voids in the extremities
研究概览
简要总结
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
详细描述
The primary purpose of this study is to collect clinical investigation data on the performance and safety of the CE-marked FDBS bone graft (GraftR3®) for the reconstruction of bony voids or bone gaps, in orthopaedic applications that are not intrinsic to the stability of the bone structure. It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue.
The study is sponsored by Advanced Medical Solutions (Nantes) and will provide essential clinical evidence to support the clinical evaluation of FDBS (GraftR3®).
For contextual interpretation, a reference arm including IBS (MBCP® Putty), a CE-marked bone substitute with established conformity to the relevant essential requirements, has been incorporated. This will allow descriptive comparison with a marketed product while maintaining the primary focus on the CE-marked device FDBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 void in one of the following anatomical locations either after traumatic injury or elective surgical reconstruction:
- •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 bone necrosis either after traumatic injury or elective surgical reconstruction at the surgical site;
- •Patient has cellulitis;
- •Patient has granuloma or non-curetted cyst;
- •Patient has a current or previous diagnosis of osteomyelitis;
- •Patient has a clinically significant degenerative bone disease;
- •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 void (cavity) 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 or breastfeeding;
- •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.
研究组 & 干预措施
FDBS (GraftR3®)
The CE-marked device FDBS (GraftR3®) is a powder that presents an interconnected network that enables the colonization of bone cells and biological fluid uniformly within the matrix required for the biological exchanges particularly for bone ingrowth.
It is intended for the reconstruction of bony voids or bone gaps in orthopaedic applications that are not intrinsic to the stability of the bone structure. It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue.
The clinical investigation is designed to generate data on the performance and safety of FDBS in orthopaedic trauma surgery.
干预措施: FDBS (GraftR3®) (Device)
IBS (MBCP® Putty)
The CE-marked device IBS (MBCP® Putty) is an injectable bone substitute to fill and reconstruct bone voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis).
It acts as a bone void filler by occupying the defect and supporting bone ingrowth from the surrounding viable tissue.
For contextual interpretation, the study will include patients treated with this technology, as published data remain limited for certain indications such as surgically created bone defects (e.g. post cyst removal) or bone gaps due to traumatic injury
干预措施: IBS (MBCP® Putty) (Device)
结局指标
主要结局
Evaluation of performance and safety of FDBS and IBS in the reconstruction of bone voids in the extremities
时间窗: At 12 months post-surgery
Achievement of successful bone integration (without occurrence of Major Adverse Events) through radiological evaluation within 12 months by assessing interdigitation in 3 out of 4 anatomical planes (anterior/posterior/lateral/medial)
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 device-related Adverse Events associated with FDBS and IBS in the reconstruction of bone voids in the extremities(Within 12 months post-surgery)
- Functional evaluation after use of FDBS and IBS in the reconstruction of bone voids in the upper extremities(Within 12 months post-surgery)
- Functional evaluation after use of FDBS and IBS in the reconstruction of bone voids in the lower extremities(Within 12 months post-surgery)
- Evaluation of subject's pain after use of FDBS and IBS in the reconstruction of bone voids in the extremities(Within 12 months post-surgery)
- Evaluation of usability of FDBS and IBS in the reconstruction of bone voids in the extremities(Within 12 months post-surgery)
- Evaluation of the difference in performance of FDBS versus IBS in the reconstruction of bone defects in the extremities(At 12 months post-surgery)
- 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)