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

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

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.

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.

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.