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

Recruitingn/aAges 18 Years - anyAllGreenBone Ortho S.p.A.
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In plain words

What the trial is, and whether it could suit you

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
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Where

4 sites
BG Klinikum Unfallkrankenhaus Berlin
Berlin, Germany
Trauma Surgery Department - University Hospital Regensburg
Regensburg, Germany
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Leeds, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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