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

Not Applicable

Completed

• Conditions: Health Status Unknown
• Interventions: Other: Magnesium-based Bone Void Filler

• Registration Number: NCT04069923
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2018-12-18
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2022-01-17
• Study Completion: 2022-01-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (OsteoCrete)	Magnesium-based Bone Void Filler	Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.

Primary Outcome Measures

Name	Time	Method
Participants reaching one year post-op and completing all study visits	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Amount of reabsorption and bone ingrowth	Up to 1 year	Will be measured in Hounsfield units by X-ray and compute tomography (CT).
Incidence of adverse events rates	Up to 1 year	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.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States