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Can a dissolvable bone wax curb bleeding during spine fusion?

NCT ID NCT06450834

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This study tests whether Ostene, a water-soluble material that plugs bleeding bone, reduces blood loss during thoracolumbar spine fusion surgery. Researchers will measure bleeding severity during surgery using a validated scale and compare results with similar past patients who did not receive Ostene. The goal is to see if Ostene lowers the need for blood transfusions and improves surgical outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ostene, a water-soluble bone hemostasis material applied to bleeding bone during spine surgery
What this could lead to
If it works, Ostene could offer a safer, more effective way to control bone bleeding during spine surgery, potentially reducing the need for blood transfusions.
What could go wrong
This is an observational comparison with past patients, not a randomized trial, so results may be influenced by other factors. Ostene's benefit over standard bone wax is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 173 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 88 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Intraoperative Complications Postoperative Complications Postoperative Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood transfusion Hemostasis Intraoperative bleeding Intraoperative blood loss Intraoperative complications Postoperative complications Postoperative hemorrhage Spine fusion Thoracolumbar spine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

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