Bone Defects
Conditions
Brief summary
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.
Interventions
DEVICEBone graft substitute
Orthopaedic or Spine bony defects
Sponsors
Bioceramed
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients treated with Bioceramed bone substitutes at the Center. * Long bone & extremities: bone grafting after post-traumatic or surgically created bone defects. * Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone healing, observable by x-ray/MRI | 6 months | Primary endpoint will be successful radiographic bone repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and description of any adverse event during the follow-up | 6 - 12 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