Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE (Ostene VIBe)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Complications; Postoperative Hemorrhage; Intraoperative Complications; Blood Transfusion; Hemostasis; Spine Fusion; Intraoperative Bleeding; Intraoperative Blood Loss; Thoracolumbar Spine
• Intervention / Treatment: Device: Ostene

Detailed Description

• 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

• Study Type: Observational
• Enrollment (Estimated): 173

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients 18 to 88 years old undergoing elective thoracolumbar decompression, instrumentation, and fusion procedures with an open, posterior approach and without indication for trauma, tumor, or suspected/confirmed infection, emergent triage status, an anterior or lateral approach, or a minimally invasive approach

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ostene; Patients who received Ostene during their thoracolumbar spine surgery	Device: Ostene; Soluble Bone Hemostasis Implant Material
No Ostene; Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood transfusion	binary and number of units	Intraoperative
postoperative blood transfusion	binary and number of units	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative hemoglobin/hematocrit		Immediately preoperative
3 days before surgery of preoperative hemoglobin/hematocrit		3 days
postoperative hemoglobin/hematocrit		3 days
days after surgery of postoperative hemoglobin/hematocrit		3 days
postoperative drain output	average daily drain output, total drain output	From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year
Presence of Deep Vein Thrombosis		From the date of surgery until 1 year follow up appointment
Presence of Pulmonary Embolism		From the date of surgery until 1 year follow up appointment
Presence of postoperative complication requiring medical intervention		From the date of surgery until 1 year follow up appointment
length of stay		From the date of surgery until discharge up to 1 year
30-day readmissions		readmission within 30 days
30-day reoperations		reoperation within 30 days
30-day emergency department visits		ED visits within 30 days
cost	total hospital billing for procedure and total episode of stay and/or insurance reimbursement amount	From the date of surgery until discharge up to 1 year

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Postoperative Complications; Blood Loss, Surgical; Postoperative Hemorrhage; Intraoperative Complications
• Other Study ID Numbers: HP-00107929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share IPD data with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes