Retrospective Collection of Safety and Performance Data

Bioceramed

Status: Terminated

Conditions: Bone Defects

Treatments: Device: Bone graft substitute

Study type: Observational

Funder types: Industry

Identifiers

NCT04644536

2020.09

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 5 patient groups

Granules in long bone & extremities

Description:

Filling of post-traumatic or surgically created bone defects

Treatment:

Device: Bone graft substitute

Wedges in long bone & extremities

Description:

Osteotomies with fixation

Treatment:

Device: Bone graft substitute

HA paste in long bone & extremities

Description:

Filling of post-traumatic or surgically created bone defects

Treatment:

Device: Bone graft substitute

Granules in Spine

Description:

Spinal cage filling

Treatment:

Device: Bone graft substitute

HA paste in Spine

Description:

Spinal cage filling

Treatment:

Device: Bone graft substitute