Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06450834
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • Ostene — DEVICE
    Soluble Bone Hemostasis Implant Material

Study Details

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.

Key Dates

Start date
Jan 17, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
173 participants (estimated)

Arms

  • Arm: Ostene
    Patients who received Ostene during their thoracolumbar spine surgery
  • Arm: No Ostene
    Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery

Primary Outcome Measure

Intraoperative blood transfusion [ Time Frame: Intraoperative ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By research site
University of Maryland Medical Center· Baltimore, MD

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