Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ostene.
- Who it may be relevant to
- Registry conditions: Intraoperative Complications, Intraoperative Bleeding, Intraoperative Blood Loss, Hemostasis. Basic parameters: 18 years — 88 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Device Ostene
Soluble Bone Hemostasis Implant Material
Primary outcome measures
- Intraoperative blood transfusion [Time frame: Intraoperative]
- postoperative blood transfusion [Time frame: 3 days]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Maryland Medical Center — Baltimore
Identifiers
NCT: NCT06450834 · HP-00107929