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

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Health Status Unknown

Treatments

Other: Magnesium-based Bone Void Filler

Study type

Interventional

Funder types

Other

Identifiers

NCT04069923

17-001785 (Other Identifier)

NCI-2018-01668 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.