A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: No
View:

• Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment.

• Subject has only one (1) acute VCF. Note that subjects are eligible if they have an asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level.

• The acute VCF meets all of the following criteria:

• Due to diagnosed or presumed underlying osteoporosis

• T1 to L5 inclusively

• Target VCF-related pain < 12 weeks at time of study treatment

• Target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.

• Target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2 weighted STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity.

• Focal tenderness to palpation of the spinal process of the target VCF on the physical exam correlates with imaging.

• Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care.

• Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.

• Subject is capable of giving written informed consent to participate in the study.

• The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented.

Locations
United States
Alabama
Alabama Clinical Therapeutics
Recruiting
Birmingham
Arizona
Mayo Clinic
Not yet recruiting
Phoenix
Washington, D.c.
GW Medical Faculty Associates
Not yet recruiting
Washington
Florida
Cleveland Clinic Florida
Recruiting
Stuart
Illinois
Rush University Medical Center
Not yet recruiting
Chicago
NorthShore University HealthSystem
Recruiting
Evanston
Kansas
University of Kansas Medical Center Research Institute, Inc.
Not yet recruiting
Kansas City
Louisiana
Louisiana Spine Institute
Recruiting
Shreveport
Massachusetts
Lahey Medical Center
Not yet recruiting
Burlington
Maryland
Anne Arundel Medical Center (AAMC)
Recruiting
Annapolis
Missouri
Washington University St. Louis
Recruiting
Saint Louis
New York
Montefiore
Recruiting
Bronx
Mt. Sinai
Not yet recruiting
New York
Oklahoma
Neuroradiology and Pain Solutions of Oklahoma
Not yet recruiting
Oklahoma City
Texas
Texas Back Institute
Not yet recruiting
Plano
Contact Information
Primary
Allison Gorman
agorman@agnovos.com
2407536424
Time Frame
Start Date: May 31, 2022
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 408
Treatments
Experimental: Treatment with 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.
Active Comparator: Treatment with PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
Authors
Jeffrey Miller, Mark Kayanja, Amish Doshi, Brian Chong, Wayne Olan, Jack Jennings, Pierce Nunley, Oszkar Szentirmai, Michael Musacchio, Chandan Krishna, William Ares, Chad Patton, Srinivas Mallempati, Shakeel Chowdhry, Neil Patel, Timothy Sowder, Kern Singh, Daewood Sayed, Andrew Sack, Dan Nguyen, Seon Kyu Lee, Bradley Goodman, Theo VanderVelde, Allen Brook, Chris Lam, Reade De Leacy
Sponsors
Leads: AgNovos Healthcare, LLC

This content was sourced from clinicaltrials.gov

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