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.
Study Type
OBSERVATIONAL
Enrollment
40
Filling bone defects in current clinical practice
Hospital Lusíadas Lisboa
Lisbon, Portugal
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 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.
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Time frame: 3 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months