Bone Defects
Conditions
Brief summary
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.
Interventions
DEVICEbone graft substitute
Filling bone defects in current clinical practice
Sponsors
Universidade Nova de Lisboa
Bioceramed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities. * Give written informed consent to participate in the study and be willing to comply with the protocol requirements. * Able to verbalize and differentiate regarding the location and intensity of pain. * Physical and mental availability to meet the clinical and radiographic follow-up schedule.
Exclusion criteria
* Serious infection within two months before surgery. * Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases. * Primary bone tumors and contraindications in performing an X-ray or CTscan. * Women of childbearing potential who are, or plan to become, pregnant during the time of the study. * The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological healing | 3 months | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and description of any adverse event during the follow-up | 3 months | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. |
Countries
Portugal
Outcome results
None listed