Extremity Injury, Orthopedic Disorder, Trauma Injury
Conditions
Keywords
Proximal humerus, Distal radius, Distal femur, Proximal tibia, Distal tibia, Fracture, MBCP Putty, Bone defect reconstruction
Brief summary
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
Detailed description
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.
Interventions
DEVICEIn'Oss™ (MBCP® Putty)
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.
Sponsors
Advanced Medical Solutions Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful bone defect reconstruction in the extremities | At 12 months post-surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of functional mobility restoration in the upper limb with PRO measures | Within 12 months post-surgery | 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) |
| Evaluation of functional mobility restoration in the lower limb with PRO measure | Within 12 months post-surgery | 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) |
| Evaluation of patient's pain intensity with VAS pain scale | Within 12 months post-surgery | 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. |
| Evaluation of safety of In'Oss | Within 12 months post-surgery | Incidence of device related Adverse Events after use of In'Oss™ (MBCP® Putty) in bone defect reconstruction in the extremities. |
| Evaluation of device usability | Within 12 months post-surgery | 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. |
Contacts
Primary ContactSusan Clark
Backup ContactLoïc Limon-Duparcmeur
Outcome results
None listed