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OpenTrials
Completed

NCT Number: NCT04069923

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

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.

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Key information

Conditions

Health Status Unknown

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium-based Bone Void Filler

Other

Given intraoperatively

Other names: Magnesium-based BVF, Osteocrete

Primary outcomes

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

    Time frame: Up to 1 year

Secondary outcomes

  1. Amount of reabsorption and bone ingrowth

    Time frame: Up to 1 year

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

  2. Incidence of adverse events rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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