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
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.
Study Type
OBSERVATIONAL
Enrollment
100
Use of In'Oss™ (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.
Successful bone defect reconstruction in the extremities
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).
Time frame: At 12 months post-surgery
Evaluation of functional mobility restoration in the upper limb with PRO measures
Functional mobility restoration in the upper limb after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction by scoring patient's physical disability and symptoms through patient-reported outcome measure (Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: Within 12 months post-surgery
Evaluation of functional mobility restoration in the lower limb with PRO measure
Functional mobility restoration in the lower limb after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction by scoring patient's physical disability and symptoms through patient-reported outcome measure: Lower Extremity Functional Scale (LEFS)
Time frame: Within 12 months post-surgery
Evaluation of patient's pain intensity with VAS pain scale
Patient's pain intensity at trauma/surgical site evaluated with Visual Analog Scale (VAS) pain scale after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction in the extremities. 0 = no pain; 10 = worst pain imagineable.
Time frame: Within 12 months post-surgery
Evaluation of safety of In'Oss
Incidence of device related Adverse Events after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction in the extremities.
Time frame: Within 12 months post-surgery
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Evaluation of device usability
Clinician satisfaction with use of In'Oss™ (MBCP® Putty) as per Instructions for Use (IFU) in bone defect reconstruction in the extremities. 0 = very unsatisfied; 5 = very satisfied.
Time frame: Within 12 months post-surgery