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

Health Status Unknown Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069923
• Other study ID #: 17-001785
• Secondary ID: NCI-2018-0166817
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: January 17, 2022

Study information

• Verified date: September 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Status Unknown

Intervention

Other:
• Magnesium-based Bone Void Filler
Given intraoperatively

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants reaching one year post-op and completing all study visits		Up to 1 year
Secondary	Amount of reabsorption and bone ingrowth	Will be measured in Hounsfield units by X-ray and compute tomography (CT).	Up to 1 year
Secondary	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