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X-BS Ortho Bone Graft Study
Sponsor: Advanced Medical Solutions Ltd.
Summary
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.
Official title: Randomised Investigation of the Osteoconductive Performance and Safety of FDBS Bone Graft, With Contextual Reference to IBS, in the Filling of Orthopaedic Bone Defects.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-10
Completion Date
2028-10
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
FDBS (GraftR3®)
Use of FDBS (GraftR3®) in 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.
IBS (MBCP® Putty)
Use of IBS (MBCP® Putty) in 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.