OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects (NCT04069923) | Clinical Trial Compass
CompletedNot Applicable
OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects
United States5 participantsStarted 2018-12-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Participants reaching one year post-op and completing all study visits