Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06450834

Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Intraoperative Complications Blood Loss, Surgical Blood Transfusion Hemorrhage Hemostasis Intraoperative Bleeding Intraoperative Blood Loss Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Spine Fusion Thoracolumbar Spine

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

  • Patients will be screened prior to surgery for inclusion and exclusion criteria.
  • If eligible, patients will be approached in the preoperative area or clinic location to consent or refuse participation in the study.
  • Baseline characteristics will be collected via a combination of patient preoperative survey and manual chart review.
  • Patients will undergo the normal surgical standard of care, receiving Ostene intraoperatively as determined appropriate by the attending spine surgeon during the procedure.
  • It is anticipated that Ostene will be used specifically during the bony work/laminectomy phase preceding decompression. Of note, this material is now considered standard of care by our principal investigator and would be used regardless of study participation.
  • Other hemostatic agents will be used according to the typical standard of care.
  • A trained research coordinator will be present to determine VIBe scores during 6 key surgical phases: 1) exposure, 2) bony work/laminectomy, 3) decompression, 4) instrumentation, 5) fusion, and 6) closure. Agreement will be obtained from the operating surgeon.
  • For all phases, the maximum VIBe score during each phase will be recorded.
  • Surgical information will be documented from the operative note.
  • Patients will receive the normal standard of care postoperatively including measure(s) of their hemoglobin/hematocrit and postoperative drain output.
  • Data on postoperative outcomes/complications will be collected from the electronic medical record.
  • A propensity-score matched cohort analysis will be constructed to compare patients who received Ostene to patients who did not receive Ostene (will use data from past study conducted from 2021-April 2023 to construct matched control cohort).
  • There will be no group assignment in this study
  • There will be no placebo group or randomization
  • Patient data from a past study will be used as a control comparator

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ostene

Device

Soluble Bone Hemostasis Implant Material

Primary outcomes

  1. Intraoperative blood transfusion

    Time frame: Intraoperative

    binary and number of units

  2. postoperative blood transfusion

    Time frame: 3 days

    binary and number of units

Secondary outcomes

  1. preoperative hemoglobin/hematocrit

    Time frame: Immediately preoperative

  2. 3 days before surgery of preoperative hemoglobin/hematocrit

    Time frame: 3 days

  3. postoperative hemoglobin/hematocrit

    Time frame: 3 days

  4. days after surgery of postoperative hemoglobin/hematocrit

    Time frame: 3 days

  5. postoperative drain output

    Time frame: From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year

    average daily drain output, total drain output

  6. Presence of Deep Vein Thrombosis

    Time frame: From the date of surgery until 1 year follow up appointment

  7. Presence of Pulmonary Embolism

    Time frame: From the date of surgery until 1 year follow up appointment

  8. Presence of postoperative complication requiring medical intervention

    Time frame: From the date of surgery until 1 year follow up appointment

  9. length of stay

    Time frame: From the date of surgery until discharge up to 1 year

  10. 30-day readmissions

    Time frame: readmission within 30 days

  11. 30-day reoperations

    Time frame: reoperation within 30 days

  12. 30-day emergency department visits

    Time frame: ED visits within 30 days

  13. cost

    Time frame: From the date of surgery until discharge up to 1 year

    total hospital billing for procedure and total episode of stay and/or insurance reimbursement amount

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Acronym: Ostene VIBe

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.