OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

Launched by GREENBONE ORTHO S.P.A. · Nov 27, 2023

Keywords

ClinConnect Summary

The OSsIRIS Study is a clinical trial designed to evaluate the safety and effectiveness of a bone substitute called b.Bone. This study focuses on patients who need surgery to treat bone defects caused by injuries or surgical procedures, particularly in the pelvis and limbs. By participating in this trial, patients will receive the standard care they need while also helping researchers gather important information about how well b.Bone works in promoting healing.

To be eligible for the trial, patients must be at least 18 years old and undergoing a standard bone grafting procedure with b.Bone. They also need to be willing to attend follow-up visits to monitor their progress. Throughout the study, patients will have assessments before surgery and at various points after the procedure, with follow-ups planned for up to two years if necessary. Importantly, all study visits will align with the patient's regular medical appointments, ensuring that participation is convenient and does not disrupt their care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
• • 2. Male or female patient ≥ 18 years old.
• • 3. Patients willing and able to attend the standard of care follow-up visits and procedures.
• • 4. Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
• Exclusion Criteria:
• • 1. Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
• • 2. Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
• • 3. Woman who is pregnant or breast-feeding.
• • 4. Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.