Retrospective Collection of Safety and Performance Data

Bioceramed1 site in 1 country50 target enrollmentNovember 25, 2020

ConditionsBone Defects

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bone Defects
Sponsor: Bioceramed
Enrollment: 50
Locations: 1
Primary Endpoint: Bone healing, observable by x-ray/MRI
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 25, 2020

End Date

November 6, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Bioceramed

Responsible Party

Sponsor

Eligibility Criteria

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.