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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | Device | All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities. b.Bone is a bone substitute without initial mechanical properties, therefore it is to be used in conjunction with internal/external fixation devices suitable for primary stabilization. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of b.Bone by determining the radiographic healing/union after surgery. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes measured by patient-reported outcomes - Pain | Change in the patient-reported pain using the Visual Analoge Scale from baseline to month 3, month 6 and month 12 post-treatment. Patient-completed questionnaire scoring pain by using 10 cm line. Zero (0) indicates no pain at all and ten (10) the worst pain ever. | Baseline and 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - bone formation | Change of bone formation 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. | Up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients both sexes requiring bone grafting with the synthetic bone substitute b.Bone, according to the standard clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Granados, MSc | Contact | +393450954463 | sonia.granados@greenbone.it | |
| Susanna Salvagno | Contact | +393497337442 | susanna.salvagno@greenbone.it |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BG Klinikum Unfallkrankenhaus Berlin | Recruiting | Berlin | 12683 | Germany |
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| Clinical outcomes measured by patient-reported outcomes - Quality of Life | Change in the patient-reported Quality of Life assessed by Health Questionnaire from baseline to month 3, month 6 and month 12 post-treatment. | Baseline and 3, 6 and 12 months |
| Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE | Number and rate of procedure and device-related adverse events (AEs) and Serious adverse events (SAEs) during the clinical investigation period. | Up to 24 months |
| Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions | Rate of reinterventions related to the treatment applied during the clinical investigation | Up to 24 months |
| Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - remodelling |
Change of remodelling 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. |
| Up to 24 months |
| Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - material resorption | Change of 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. | Up to 24 months |
| Exploratory outcomes: Evaluate the performance of b.Bone on different anatomical sites of implantation. | b.Bone performance on different subsets of patients depending on the anatomical site of implantation:
(The performance will be assessed as defined for the primary and secondary outcomes) | Baseline and 3, 6 ,12, 24 months |
| Trauma Surgery Department - University Hospital Regensburg | Recruiting | Regensburg | 93053 | Germany |
|
| Hull University Teaching Hospitals NHS Trust | Recruiting | Hull | HU3 2JZ | United Kingdom |
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| Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary | Recruiting | Leeds | LS13EX | United Kingdom |
|
| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
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