OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects

Study Overview
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Brief Summary
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This trial studies the side effects of OsteoCrete in filling bone voids in participants with bone voids or defects. OsteoCrete may eliminate the need for further surgery and the removal of healthy bone.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone. SECONDARY OBJECTIVES: I. To determine the rate of absorption and bone ingrowth. OUTLINE: Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation. After completion of study treatment, participants are followed for up to 1 year.

Official Title
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Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure

Conditions
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Health Status Unknown

Intervention / Treatment
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* Other: Magnesium-based Bone Void Filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria: Bone void created during surgery. Lucency noted on x-ray preoperatively. Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. Creatinine greater than 1.3. Presence of active bone infection.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (OsteoCrete)<br>Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation. | Other: Magnesium-based Bone Void Filler<br>* Given intraoperatively<br>* Other names: Osteocrete;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants reaching one year post-op and completing all study visits |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of reabsorption and bone ingrowth | Will be measured in Hounsfield units by X-ray and compute tomography (CT). | Up to 1 year | 
| Incidence of adverse events rates | Will be coded by body system and MedDra classification term. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study device. | Up to 1 year |