Status:
COMPLETED
OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Health Status Unknown
Eligibility:
All Genders
18+ years
Phase:
NA
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 bon...
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 absor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04069923
Start Date
December 18 2018
End Date
January 17 2022
Last Update
September 23 2022
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095