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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04069923

Enrollment

Registered

2019-08-28

Start date

2018-12-18

Completion date

2022-01-17

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Status Unknown

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.

Interventions

OTHERMagnesium-based Bone Void Filler

Given intraoperatively

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026