Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jun 4, 2024

Keywords

ClinConnect Summary

This study is looking at whether a bone-healing material called Ostene helps reduce bleeding during certain spine surgeries. Ostene is placed on the bone to help stop bleeding and dissolves over time. The researchers will measure how much bleeding occurs at several moments during the operation using a standard bleeding scale, and then compare those results to similar patients from a past study who did not receive Ostene. This is an observational study, not a randomized trial, and it will also track things like transfusions, drain output, complications, hospital stay, and certain costs for up to a year after surgery.

If you might be eligible, you would be an adult between 18 and 88 years old undergoing an elective thoracolumbar spine procedure that includes decompression, instrumentation, and fusion with an open approach from the back. Eligible patients will consent to participate, and Ostene would be used during the bone work as decided by the surgeon, with other usual bleeding-control methods also used. You would undergo routine preoperative testing and postoperative follow-up, and researchers will collect data on your recovery and any complications for up to a year. The trial is currently enrolling by invitation at the University of Maryland Medical Center, aiming for about 173 participants, with results expected after the study completes in 2027.

Gender

ALL

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