X-BS Ortho Bone Graft Study

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.