In'Oss™ (MBCP® Putty) Ortho

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a product called In'Oss™ (MBCP® Putty), which is an injectable bone substitute designed to help fill in areas where bone is missing due to injuries or conditions affecting the bones in the arms and legs. The aim is to gather information about how well this product works in helping bones heal after surgery. The trial is not yet recruiting participants, but it plans to include men and women aged 18 to 85 who are scheduled for surgery to repair specific types of bone defects in areas like the shoulder, wrist, thigh, or lower leg.

Participants in the trial will need to be able to give their consent and follow the study procedures during and after their surgery, which will last up to 12 months. However, there are some health conditions that might prevent someone from participating, such as recent infections, severe bone loss, or certain medical treatments that could interfere with the study. If you are considering participating, you can expect to receive care during your surgery and follow-up appointments to monitor your recovery and the effectiveness of the In'Oss™ putty.

Gender

ALL

Eligibility criteria

• 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.