408
Participants
Start Date
May 31, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2027
Treatment Group: AGN1 LOEP SV Kit
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.
Control Group: PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
WITHDRAWN
Mt. Sinai, New York
RECRUITING
Montefiore, The Bronx
WITHDRAWN
GW Medical Faculty Associates, Washington D.C.
WITHDRAWN
Anne Arundel Medical Center (AAMC), Annapolis
RECRUITING
Pinehurst Surgical Clinic, Pinehurst
RECRUITING
Orlando Neurosurgery (Conquest Research), Orlando
RECRUITING
Cleveland Clinic Florida, Stuart
RECRUITING
Alabama Clinical Therapeutics, Birmingham
RECRUITING
NorthShore University HealthSystem, Evanston
WITHDRAWN
Duly Health / NextStage Clinical Research, Naperville
RECRUITING
Rush University Medical Center, Chicago
RECRUITING
Washington University St. Louis, St Louis
RECRUITING
University of Kansas Medical Center Research Institute, Inc., Kansas City
WITHDRAWN
Abay Neuroscience Center / NextStage Clinical Research, Wichita
RECRUITING
Louisiana Spine Institute, Shreveport
ACTIVE_NOT_RECRUITING
Texas Back Institute, Plano
WITHDRAWN
Mayo Clinic, Phoenix
RECRUITING
Elite Pain and Spine Institute, Mesa
RECRUITING
Lahey Medical Center, Burlington
AgNovos Healthcare, LLC
INDUSTRY