NCT04069923

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Health Status Unknown

Interventions

Type	Name	Description
OTHER	Magnesium-based Bone Void Filler	Given intraoperatively

Timeline

• Start date: 2018-12-18
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2019-08-28
• Last updated: 2022-09-23

Locations

1 site across 1 country: United States