Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA Paste in Spine | Evaluation of HA Paste in spinal fusion procedures o Spinal cage filling |
| |
| HA Paste in long bone & extremities | Evaluation of HA Paste in long bone and extremity group:
|
| |
| Granulated Paste in Spine | Evaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling |
| |
| Granulated Paste in long bone & extremities | Evaluation of Granulated Paste in long bone and extremity group:
|
| |
| Granules in Spine | Evaluation of Granules in spinal fusion procedures o Spinal cage filling |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone graft substitute | Device | orthopaedic or spine bony defects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoints will be successful radiographic bone repair. | Bone formation and material resorption, observable by x-ray/MRI | 12 months |
Not provided
Not provided
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.
Not provided
Not provided
male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust | Doncaster | South Yorkshire | DN2 5LT | United Kingdom | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Granules in long bone & extremities |
Evaluation of Granules in long bone and extremity group:
|
|
| Block in long bone & extremities | Evaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation |
|
| Sandwell and West Birmingham NHS Trust of City Hospital |
| Birmingham |
| United Kingdom |
| The Royal Orthopaedic Hospital NHS Foundation Trust | Birmingham | United Kingdom |
| Northumbria Healthcare NHS Foundation Trust | North Shields | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | United Kingdom |
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | United Kingdom |
| Taunton and Somerset NHS Foundation Trust | Taunton | United Kingdom |