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The study was terminated following a change in company management.
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This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granules in long bone & extremities | Filling of post-traumatic or surgically created bone defects |
| |
| Wedges in long bone & extremities | Osteotomies with fixation |
| |
| HA paste in long bone & extremities | Filling of post-traumatic or surgically created bone defects |
| |
| Granules in Spine | Spinal cage filling |
| |
| HA paste in Spine | Spinal cage filling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone graft substitute | Device | Orthopaedic or Spine bony defects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone healing, observable by x-ray/MRI | Primary endpoint will be successful radiographic bone repair. | 6 months |
| Bone healing, observable by x-ray/MRI | Primary endpoint will be successful radiographic bone repair. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 6 - 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.
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All study patients will be extracted from current patient population.
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| Name | Affiliation | Role |
|---|---|---|
| Nuno A Ribeiro, MD | Hospital LusÃadas Lisboa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital LusÃadas Lisboa | Lisbon | Portugal |
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