OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
Study Details
Study Description
Brief Summary
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 metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.
All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.
It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Performance of b.Bone by determining the radiographic healing/union after surgery. [12 months]
Number and rate of patients with successful bone healing/union observable by X-ray or CT scan. Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.
Secondary Outcome Measures
- Clinical outcomes measured by patient-reported outcomes (PROs) [Baseline and 3, 6 and 12 months]
Change in the patient-reported QoL assessed by EQ-5D-5L and pian using VAS score from baseline to month 3, month 6 and month 12 post-treatment.
- Evaluate the safety of b.Bone during the clinical investigation period. [Up to 24 months]
Number and rate of procedure and device-related adverse events (AEs) and Serious adverse events (SAEs) during the clinical investigation period. Rate of reinterventions related to the treatment applied during the clinical investigation
Other Outcome Measures
- Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameters (bone formation, remodelling and material resorption) after b.Bone implantation. [Up to 24 months]
Change of complementary radiographic parameters (bone formation, remodelling and material resorption) observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan. These changes will be evaluated: within 12 months for those patients who successfully show bone healing/union up to 24 months in patients who require longer follow-up and could be subjected to metalwork removal* (*The length of follow-up and the decision to perform a metalwork removal would be decided by the surgeon)
- Exploratory outcomes: Evaluate the performance of b.Bone on different subsets of patients depending on the anatomical site of implantation. [Baseline and 3, 6 ,12, 24 months]
b.Bone performance** on different subsets of patients depending on the anatomical site of implantation: subset a: pelvis subset b: upper extremities subset c: lower extremities (** The performance will be assessed as defined for the primary and secondary outcomes)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Male or female patient ≥ 18 years old.
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Patients willing and able to attend the standard of care follow-up visits and procedures.
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Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
Exclusion Criteria:
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Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
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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.
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Woman who is pregnant or breast-feeding.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Trauma Surgery Department - University Hospital Regensburg | Regensburg | Germany | ||
| 2 | Hull University Teaching Hospitals NHS Trust | Hull | United Kingdom | HU3 2JZ | |
| 3 | Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary | Leeds | United Kingdom | LS13EX |
Sponsors and Collaborators
- GreenBone Ortho S.p.A.
Investigators
- Principal Investigator: Volker Alt, Dr, Director of the Trauma Surgery Department University Hospital Regensburg, Germany
- Principal Investigator: Peter Giannoudis, Dr, Honorary Consultant Trauma & Orthopaedic Surgery, Leeds General Infirmary, United Kingdom
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-GB002-22-0123