Could a new injection replace bone cement for spine fractures?

NCT ID NCT04835428

Ongoing Disease control Sponsor: AgNovos Healthcare, LLC Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new device (AGN1 LOEP) to standard bone cement for treating painful spine fractures caused by osteoporosis. The new device is injected into the broken vertebra, where it hardens and then slowly gets replaced by new bone. The trial involves 408 adults aged 50 and older with recent fractures. The goal is to see if the new device works as well as cement for pain relief and function, while also promoting bone regrowth.

What this could mean

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

Active substance: AGN1 LOEP SV Kit (a device that is injected into the fractured vertebra, resorbed, and replaced by new bone)
What this could lead to: If it works, this could offer a treatment for painful spine fractures that helps the body regrow bone rather than just filling the crack with cement.
What could go wrong: This is an early-stage non-inferiority trial, so the new device may not be as effective as standard cement. Risks include device-related complications or the need for further surgery.

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

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Conditions

The condition(s) this trial relates to.

Fractures, Compression spinal fracture

As listed by the trial registrant

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

COMPRESSION FRACTURE VERTEBRAL COMPRESSION VERTEBRAL COMPRESSION FRACTURE

Contacts and locations

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States
Cleveland Clinic Florida

Stuart, Florida, 34994, United States
Elite Pain and Spine Institute

Mesa, Arizona, 85203, United States
Endeavor Health

Evanston, Illinois, 60201, United States
Lahey Medical Center

Burlington, Massachusetts, 01805, United States
Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States
Montefiore

The Bronx, New York, 10467, United States
Orlando Neurosurgery (Conquest Research)

Orlando, Florida, 32804, United States
Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
Texas Back Institute

Plano, Texas, 75093, United States
University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

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