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

Jonsson Comprehensive Cancer Center5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Health Status Unknown

Interventions

Magnesium-based Bone Void FillerOTHER

Given intraoperatively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Participants reaching one year post-op and completing all study visits

Time frame: Up to 1 year

Secondary Outcomes

Amount of reabsorption and bone ingrowth

Will be measured in Hounsfield units by X-ray and compute tomography (CT).

Time frame: Up to 1 year

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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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