STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures

NCT04835428 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: AGN-CIP-201STAND
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Vertebral Compression Fracture; Compression Fracture; Vertebral Compression

Keywords

LOEP; AGN1; STAND; Local Osteo-Enhancement Procedure

Outcome Measures

Primary Outcomes (5)

• Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)

  Change in VCF-related pain by \> 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible.

  24 months

• Change in function

  change of function from baseline as measured by the Oswestry Disability Index (ODI)

  24 months

• Radiographic evidence of implant resorption (Intervention Group only)

  change in resorption from procedure as assessed by independent radiographer

  24 months

• Radiographic evidence of bone formation (Intervention Group only)

  change in bone formation from procedure as assessed by independent radiographer

  24 months

• Adverse events

  Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment

  24 months

Study Arms (2)

Treatment with AGN1 LOEP SV Kit

EXPERIMENTAL

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.

Device: Treatment Group: AGN1 LOEP SV Kit

Treatment with PMMA bone cement

ACTIVE COMPARATOR

High viscosity PMMA bone cement will be used for vertebral augmentation.

Device: Control Group: PMMA bone cement

Interventions

Treatment Group: AGN1 LOEP SV Kit DEVICE

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.

Treatment with AGN1 LOEP SV Kit

Control Group: PMMA bone cement DEVICE

High viscosity PMMA bone cement will be used for vertebral augmentation.

Treatment with PMMA bone cement

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or female 50 years of age or older at the time of study treatment.
• Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if they have an asymptomatic, healed VCF(s) at any non-target vertebral level.
• Each target VCF meets all of the following criteria:
• Due to diagnosed or presumed underlying osteoporosis
• T1 to L5 inclusively
• Target VCF-related pain ≤ 6 months at time of study treatment
• Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
• Each 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 each 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

You may not qualify if:

• At least one of the target VCF(s) is unstable, including split or burst fracture.
• Subject has a bleeding disorder.
• Subject has an active infection of the spine or surgical site.
• Subject has a bloodborne infection.
• At least one of the target VCFs is due to underlying or suspected tumor.
• At least one of the target VCFs is due to high-energy trauma.
• At least one of the target VCFs is due to osteonecrosis.
• At least one of the target VCFs has a local kyphotic angle of \> 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF.
• Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
• The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.
• Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).
• Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
• Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.
• Subject has spondylolisthesis \> Grade 1 at target vertebral body(ies).
• Subject requires daily opioid medication for pain not related to the target VCF(s).

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (12)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Elite Pain and Spine Institute

Mesa, Arizona, 85203, United States

Location

Orlando Neurosurgery (Conquest Research)

Orlando, Florida, 32804, United States

Location

Cleveland Clinic Florida

Stuart, Florida, 34994, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Endeavor Health

Evanston, Illinois, 60201, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States

Location

Lahey Medical Center

Burlington, Massachusetts, 01805, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Fractures, Compression

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Kern Singh

  Midwest Orthopedics at Rush

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study subjects will not be informed of their treatment group assignment at the time of randomization or at any time before the subject's last office visit. The blind will be broken only if it is necessary to protect the safety or welfare of the subject as determined by the Investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Four hundred eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: May 31, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)