CERAMENT™| Bone Void Filler Device Registry

Study Overview
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Brief Summary
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A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Detailed Description
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A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Official Title
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CERAMENT™| Bone Void Filler Device Registry

Conditions
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Orthopedic Disorder

Intervention / Treatment
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* Device: CERAMENT BVF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and over (on the day of surgery) Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product In receipt of patient information leaflet and have signed appropriately designed informed consent Exclusion Criteria: Any exclusion criteria as per IFU for CERAMENT BVF Any off-label use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CERAMENT BVF|CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months | 
| Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months | 
| Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months | 
| Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months | 
| Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 and 18 months | 
| Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months | 
| adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months | 
| SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 12 months | 
| SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological assessment at 6 and 12 months. Objective assessment of regeneration | Bone healing | 6 Months | 
| Radiological assessment at 6 and 12 months. Objective assessment of regeneration | Bone healing | 12 Months | 
| Pain VAS score | Pain assessment at 6,12, and 18 months | 6, 12, and 18 Months | 
| EQ-5D-3L | Functional assessment at 6, 12, and 18 months | 6, 12, and 18 months |