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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06450834
- Acronym / sponsor ID
- Ostene VIBe / HP-00107929
- Conditions
- Intraoperative Complications, Intraoperative Bleeding, Intraoperative Blood Loss, Hemostasis, Blood Transfusion, Postoperative Hemorrhage
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ostene | – | Device: OstenePatients who received Ostene during their thoracolumbar spine surgery |
| No Ostene | – | –Propensity score matched cohort from previous study that did not receive Ostene during their spine surgery |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Indication for trauma, tumor, or suspected/confirmed infection
- Emergent triage status
- Anterior or lateral approach
- Minimally invasive approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteneSoluble Bone Hemostasis Implant Material | Device | Ostene |
Primary outcome
Intraoperative blood transfusion
Time frame: Intraoperative
binary and number of units
postoperative blood transfusion
Time frame: 3 days
binary and number of units
13 secondary outcomes
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
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
Time frame: From the date of surgery until discharge up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD data with any other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Complications and Intraoperative Bleeding, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood transfusion (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.