Calcium Phosphate Cement as Bone Void Filler

Study Overview
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Brief Summary
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This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.

Official Title
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CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery

Conditions
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Bone Defects

Intervention / Treatment
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* Device: bone graft substitute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities. Give written informed consent to participate in the study and be willing to comply with the protocol requirements. Able to verbalize and differentiate regarding the location and intensity of pain. Physical and mental availability to meet the clinical and radiographic follow-up schedule. Exclusion Criteria: Serious infection within two months before surgery. Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases. Primary bone tumors and contraindications in performing an X-ray or CTscan. Women of childbearing potential who are, or plan to become, pregnant during the time of the study. 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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Calcium Phosphate Cement (CPC)<br>Evaluation of CPC in long bone & extremities | Device: bone graft substitute<br>* Filling bone defects in current clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 3 months | 
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 6 months | 
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 9 months | 
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 12 months | 
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 18 months | 
| Radiological healing | Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 3 months | 
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 6 months | 
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 9 months | 
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 12 months | 
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 18 months | 
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 24 months |