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NCT06450834

Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: Prospective, Propensity-score Matched Cohort Analysis Evaluating the Use of Ostene Bone Hemostasis Material During Thoracolumbar Decompression, Instrumentation, and Fusion Using a Validated Intraoperative Bleeding Scale

Key Details

Gender

All

Age Range

18 Years - 88 Years

Study Type

OBSERVATIONAL

Enrollment

173

Start Date

2025-01-17

Completion Date

2027-06

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DEVICE

Ostene

Soluble Bone Hemostasis Implant Material

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States