An observational study in Intraoperative Complications, Intraoperative Bleeding and Intraoperative Blood Loss, sponsored by University of Maryland, Baltimore. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Maryland, Baltimore · Observational
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.
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).
78 studies on the registry are indexed under Intraoperative Complications; 17 are open to participants now.
This study's planned enrollment of 173 is close to the median of 160 across 35 observational studies indexed under Intraoperative Complications.
Browse Intraoperative Complications studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients who received Ostene during their thoracolumbar spine surgery
Device: Ostene
Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery
Soluble Bone Hemostasis Implant Material
Intraoperative blood transfusion
binary and number of units
Time frame: Intraoperative
postoperative blood transfusion
binary and number of units
Time frame: 3 days
preoperative hemoglobin/hematocrit
Time frame: Immediately preoperative
3 days before surgery of preoperative hemoglobin/hematocrit
Time frame: 3 days
postoperative hemoglobin/hematocrit
Time frame: 3 days
days after surgery of postoperative hemoglobin/hematocrit
Time frame: 3 days
postoperative drain output
average daily drain output, total drain output
Time frame: From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year
Presence of Deep Vein Thrombosis
Time frame: From the date of surgery until 1 year follow up appointment
Presence of Pulmonary Embolism
Time frame: From the date of surgery until 1 year follow up appointment
Presence of postoperative complication requiring medical intervention
Time frame: From the date of surgery until 1 year follow up appointment
length of stay
Time frame: From the date of surgery until discharge up to 1 year
30-day readmissions
Time frame: readmission within 30 days
30-day reoperations
Time frame: reoperation within 30 days
30-day emergency department visits
Time frame: ED visits within 30 days
cost
total hospital billing for procedure and total episode of stay and/or insurance reimbursement amount
Time frame: From the date of surgery until discharge up to 1 year
Plan to share: No — There is currently no plan to share IPD data with any other researchers.
No publications or documents are linked to this record.
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University of Maryland, Baltimore