Intraoperative ComplicationsOstene VIBeNCT06450834
Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE
An observational study of Intraoperative Complications and Intraoperative Bleeding, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Intraoperative Complications, Intraoperative Bleeding, Intraoperative Blood Loss
- What is being tested?
- Ostene
- Type of treatment
- Medical device
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Indication for trauma, tumor, or suspected/confirmed infection
- Emergent triage status
- Anterior or lateral approach
- Minimally invasive approach
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official 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
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.
Read the 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
- Conditions
- Intraoperative Complications, Intraoperative Bleeding, Intraoperative Blood Loss, Hemostasis, Blood Transfusion, Postoperative Hemorrhage
- Being tested
- Ostene
- Medical subject headings
- Intraoperative Complications, Blood Loss, Surgical, Postoperative Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteneDevice
Soluble Bone Hemostasis Implant Material
| Study group | Role | What they receive |
|---|---|---|
| Ostene | Patients who received Ostene during their thoracolumbar spine surgery Receives: Device: Ostene | |
| No Ostene | Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood transfusion
binary and number of units
Measured: Intraoperative
postoperative blood transfusion
binary and number of units
Measured: 3 days
Secondary outcomes (13)
preoperative hemoglobin/hematocrit
Measured: Immediately preoperative
3 days before surgery of preoperative hemoglobin/hematocrit
Measured: 3 days
postoperative hemoglobin/hematocrit
Measured: 3 days
days after surgery of postoperative hemoglobin/hematocrit
Measured: 3 days
postoperative drain output
average daily drain output, total drain output
Measured: From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year
Presence of Deep Vein Thrombosis
Measured: From the date of surgery until 1 year follow up appointment
Presence of Pulmonary Embolism
Measured: From the date of surgery until 1 year follow up appointment
Presence of postoperative complication requiring medical intervention
Measured: From the date of surgery until 1 year follow up appointment
length of stay
Measured: From the date of surgery until discharge up to 1 year
30-day readmissions
Measured: readmission within 30 days
30-day reoperations
Measured: reoperation within 30 days
30-day emergency department visits
Measured: ED visits within 30 days
cost
total hospital billing for procedure and total episode of stay and/or insurance reimbursement amount
Measured: From the date of surgery until discharge up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start17 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Steven Ludwig, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450834
- Sponsor's protocol ID
- HP-00107929
- Acronym
- Ostene VIBe
- Status last verified
- Aug 2026
- First submitted
- 28 May 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is currently no plan to share IPD data with any other researchers.