Clinical trial NCT06450834: Ostene in Thoracolumbar Decompression and Fusion Evaluated with VIBE
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Intraoperative Complications
Intraoperative Bleeding
Intraoperative Blood Loss
Hemostasis
Blood Transfusion
Postoperative Hemorrhage
Postoperative Complications
Spine Fusion
Thoracolumbar Spine
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Baxter International Inc.
First posted: 2024-06-10
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative blood transfusion
timeFrame: Intraoperative
measure: postoperative blood transfusion
timeFrame: 3 days
Secondary outcomes:
measure: preoperative hemoglobin/hematocrit
timeFrame: Immediately preoperative
measure: 3 days before surgery of preoperative hemoglobin/hematocrit
timeFrame: 3 days
measure: postoperative hemoglobin/hematocrit
timeFrame: 3 days
measure: days after surgery of postoperative hemoglobin/hematocrit
timeFrame: 3 days
measure: postoperative drain output
timeFrame: From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year
measure: Presence of Deep Vein Thrombosis
timeFrame: From the date of surgery until 1 year follow up appointment
measure: Presence of Pulmonary Embolism
timeFrame: From the date of surgery until 1 year follow up appointment
measure: Presence of postoperative complication requiring medical intervention
timeFrame: From the date of surgery until 1 year follow up appointment
measure: length of stay
timeFrame: From the date of surgery until discharge up to 1 year
measure: 30-day readmissions
timeFrame: readmission within 30 days
measure: 30-day reoperations
timeFrame: reoperation within 30 days
measure: 30-day emergency department visits
timeFrame: ED visits within 30 days
measure: cost
timeFrame: From the date of surgery until discharge up to 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: