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Enrolling By Invitation NCT06450834

Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Conditions: Intraoperative Complications, Intraoperative Bleeding, Intraoperative Blood Loss, Hemostasis, Blood Transfusion, Postoperative Hemorrhage, Postoperative Complications, Spine Fusion, Thoracolumbar Spine

Sex: All
Ages: 18 Years – 88 Years
Healthy volunteers: No
Enrollment: 173
Sponsor: University of Maryland, Baltimore

Location: University of Maryland Medical Center Baltimore Maryland

Summary

In spine surgery, it is important to try to minimize bleeding. In particular, spine surgery often involves inserting hardware into bone, and/or removing bone in the spine. Because the bone in the spine contains blood vessels, there can often be bleeding from the bone itself that is difficult to stop completely. One way to stop bone bleeding is through the use of wax-like materials, which plug the bleeding bone and act as a physical barrier to stop bleeding. One example is Ostene bone hemostasis material, which has the advantage of being "water soluble", meaning it will dissolve naturally over time. The purpose of this study is to evaluate how well Ostene does at decreasing bleeding, by using a recognized scale called the validated intraoperative bleeding severity scale, abbreviated as "VIBe". In this study, the investigators will record the bleeding severity throughout multiple time points in surgery using this scale, and then the investigators will compare the measurements to patients in the past who did not receive Ostene. Overall, this research will help measure how well Ostene decreases bleeding.

Eligibility Criteria

Inclusion Criteria: * Adult patients 18 to 88 years old * Elective thoracolumbar decompression, instrumentation, and fusion procedure * Open, posterior approach * Patients included for analysis in a related prior study which had enrollment criteria congruent with the current study Exclusion Criteria: * Indication for trauma, tumor, or suspected/confirmed infection * Emergent triage status * Anterior or lateral approach * Minimally invasive approach

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06450834). StuddyBuddy aggregates publicly available trial information.