Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Postoperative Complications Clinical Trial

— Ostene 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450834
• Other study ID #: HP-00107929
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: John Carbone, BS
• Phone: 4436325426
• Email: johncarbone[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 173
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Blood Transfusion
• Hemorrhage
• Hemostasis
• Intraoperative Bleeding
• Intraoperative Blood Loss
• Intraoperative Complications
• Postoperative Complications
• Postoperative Hemorrhage
• Spine Fusion
• Thoracolumbar Spine

Intervention

Device:
• Ostene
Soluble Bone Hemostasis Implant Material

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Baxter International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood transfusion	binary and number of units	Intraoperative
Primary	postoperative blood transfusion	binary and number of units	3 days
Secondary	preoperative hemoglobin/hematocrit		Immediately preoperative
Secondary	3 days before surgery of preoperative hemoglobin/hematocrit		3 days
Secondary	postoperative hemoglobin/hematocrit		3 days
Secondary	days after surgery of postoperative hemoglobin/hematocrit		3 days
Secondary	postoperative drain output	average daily drain output, total drain output	From the first day postoperatively then measured daily, until the patient is discharged, up to 1 year
Secondary	Presence of Deep Vein Thrombosis		From the date of surgery until 1 year follow up appointment
Secondary	Presence of Pulmonary Embolism		From the date of surgery until 1 year follow up appointment
Secondary	Presence of postoperative complication requiring medical intervention		From the date of surgery until 1 year follow up appointment
Secondary	length of stay		From the date of surgery until discharge up to 1 year
Secondary	30-day readmissions		readmission within 30 days
Secondary	30-day reoperations		reoperation within 30 days
Secondary	30-day emergency department visits		ED visits within 30 days
Secondary	cost	total hospital billing for procedure and total episode of stay and/or insurance reimbursement amount	From the date of surgery until discharge up to 1 year