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Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

NCT06450834 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

  • Intraoperative Complications
  • Intraoperative Bleeding
  • Intraoperative Blood Loss
  • Hemostasis
  • Blood Transfusion
  • Postoperative Hemorrhage
  • Postoperative Complications
  • Spine Fusion
  • Thoracolumbar Spine

Interventions

DEVICE

Ostene

Soluble Bone Hemostasis Implant Material

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450834 on ClinicalTrials.gov