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The study was terminated following a change in company management.
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| Name | Class |
|---|---|
| Universidade Nova de Lisboa | OTHER |
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This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Phosphate Cement (CPC) | Evaluation of CPC in long bone & extremities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone graft substitute | Device | Filling bone defects in current clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 3 months |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 6 months |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 9 months |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 12 months |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 18 months |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 24 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. | 3 months |
| Number and description of any adverse event during the follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.
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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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Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. |
| 6 months |
| 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. | 9 months |
| 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. | 12 months |
| 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. | 18 months |
| 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. | 24 months |