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NOT YET RECRUITING
NCT06326827
NA

X-BS Ortho Bone Graft Study

Sponsor: Advanced Medical Solutions Ltd.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.