Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications. (ROSA)

Ceramisys

Status: Active, not recruiting

Conditions: Bone Deformity

Treatments: Device: bone graft substitute

Study type: Observational

Funder types: Industry

Identifiers

NCT03570606

ROSA01

Details and patient eligibility

About

This is an observational, prospective, non-randomised, multi-centred 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: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

Spine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.

Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;

Exclusion criteria

Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Trial design

220 participants in 7 patient groups

HA Paste in Spine

Description:

Evaluation of HA Paste in spinal fusion procedures o Spinal cage filling

Treatment:

Device: bone graft substitute

HA Paste in long bone & extremities

Description:

Evaluation of HA Paste in long bone and extremity group: * Filling bone defects after cyst removal * Filling distal radius fractures * Filling defects such as tibial plateau fractures * Filling defects created by osteotomy procedures

Treatment:

Device: bone graft substitute

Granulated Paste in Spine

Description:

Evaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling

Treatment:

Device: bone graft substitute

Granulated Paste in long bone & extremities

Description:

Evaluation of Granulated Paste in long bone and extremity group: * Filling bone defects after cyst removal * Filling distal radius fractures * Filling defects such as tibial plateau fractures * Filling defects created by osteotomy procedures

Treatment:

Device: bone graft substitute

Granules in Spine

Description:

Evaluation of Granules in spinal fusion procedures o Spinal cage filling

Treatment:

Device: bone graft substitute

Granules in long bone & extremities

Description:

Evaluation of Granules in long bone and extremity group: * Filling bone defects after cyst removal * Filling distal radius fractures * Filling defects such as tibial plateau fractures * Filling defects created by osteotomy procedures

Treatment:

Device: bone graft substitute

Block in long bone & extremities

Description:

Evaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation

Treatment:

Device: bone graft substitute