Orthopedic Disorder Clinical Trial
Official title:
Study of the Osteoconductive Potential of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) in the Filling of Orthopaedic Bone Defects
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
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Patient is male or female, 18 - 85 years old; 2. Patient is willing and able to give written informed consent; 3. Patient is able to comply with a prior medical examination; 4. Patient is or has been scheduled for a 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 5. 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: 1. Patient has had an infection in the same extremity within last 24 months; 2. Patient has signs of necrosis at the surgical site; 3. Patient has cellulitis; 4. Patient has granuloma or non-curetted cyst; 5. Patient has an history of uncontrolled diabetes; 6. Patient is alcoholic and/or heavy smoker (> 20 cigarettes per day); 7. Patient has a congenital or acquired immunodeficiency; 8. Patient has severe bone loss (= 40cm3); 9. Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism; 10. Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device; 11. Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created; 12. 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; 13. Patient is pregnant; 14. Patient who is an employee at the study site; 15. Patient is known to be non-compliant with medical treatment or follow-up 16. 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; 17. 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Advanced Medical Solutions Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | At 12 months post-surgery | |
Secondary | 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) | Within 12 months post-surgery | |
Secondary | 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) | Within 12 months post-surgery | |
Secondary | 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. |
Within 12 months post-surgery | |
Secondary | 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. | Within 12 months post-surgery | |
Secondary | 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. |
Within 12 months post-surgery |
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