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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.

Conditions
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Bone Deformity

Intervention / Treatment
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* Device: bone graft substitute


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HA Paste in Spine<br>Evaluation of HA Paste in spinal fusion procedures o Spinal cage filling | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| HA Paste in long bone & extremities<br>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 | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| Granulated Paste in Spine<br>Evaluation of Granulated Paste in spinal fusion procedures o Spinal cage filling | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| Granulated Paste in long bone & extremities<br>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 | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| Granules in Spine<br>Evaluation of Granules in spinal fusion procedures o Spinal cage filling | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| Granules in long bone & extremities<br>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 | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|
| Block in long bone & extremities<br>Evaluation of Blocks in long bone and extremity group: o High tibial osteotomies with fixation | Device: bone graft substitute<br>* orthopaedic or spine bony defects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoints will be successful radiographic bone repair. | Bone formation and material resorption, observable by x-ray/MRI | 12 months |