Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

NCT06450834 | Enrolling By Invitation FDA Device

• 1 other identifier: HP-00107929
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood transfusion

  binary and number of units

  Intraoperative

• postoperative blood transfusion

  binary and number of units

  3 days

Secondary Outcomes (13)

• 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

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

Study Arms (2)

Ostene

Patients who received Ostene during their thoracolumbar spine surgery

Device: Ostene

No Ostene

Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery

Interventions

Ostene DEVICE

Soluble Bone Hemostasis Implant Material

Ostene

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Indication for trauma, tumor, or suspected/confirmed infection
• Emergent triage status
• Anterior or lateral approach
• Minimally invasive approach

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Intraoperative Complications; Blood Loss, Surgical; Postoperative Hemorrhage; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedics

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 10, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)