STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
NCT ID: NCT04835428
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
408 participants
INTERVENTIONAL
2022-05-31
2027-12-31
Brief Summary
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Detailed Description
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1. Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
2. Active Control Group - receives vertebral augmentation of the target VCF(s) using either Stryker VertaPlex HV or Medtronic Kyphon HV-R.
Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Treatment with PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
Control Group: PMMA bone cement
High viscosity PMMA bone cement will be used for vertebral augmentation.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Each target VCF meets all of the following criteria:
1. Due to diagnosed or presumed underlying osteoporosis
2. T1 to L5 inclusively
3. Target VCF-related pain ≤ 6 months at time of study treatment
4. Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
5. 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.
6. Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
7. 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.
8. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
9. Subject is capable of giving written informed consent to participate in the study.
10. 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
Exclusion Criteria
2. Subject has a bleeding disorder.
3. Subject has an active infection of the spine or surgical site.
4. Subject has a bloodborne infection.
5. At least one of the target VCFs is due to underlying or suspected tumor.
6. At least one of the target VCFs is due to high-energy trauma.
7. At least one of the target VCFs is due to osteonecrosis.
8. 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.
9. Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
10. The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.
11. Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).
12. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
13. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.
14. Subject has spondylolisthesis \> Grade 1 at target vertebral body(ies).
15. Subject requires daily opioid medication for pain not related to the target VCF(s).
16. Subject has severe cardiopulmonary deficiencies.
17. Subject has a Body Mass Index (BMI) \> 35.
18. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
19. Subject has a history of tuberculous spondylitis.
20. Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then.
21. Subject is on oral or parenteral immune-suppressive drugs.
22. Subject has uncontrolled diabetes mellitus.
23. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min.
24. Subject has a diagnosed calcium metabolism disorder.
25. Subject has known allergies to calcium-based bone void fillers.
26. Subject is pregnant or planning to become pregnant during participation in the study.
27. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit).
28. Subject is currently enrolled in another interventional clinical study.
50 Years
ALL
No
Sponsors
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AgNovos Healthcare, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kern Singh
Role: PRINCIPAL_INVESTIGATOR
Midwest Orthopedics at Rush
Locations
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Orlando Neurosurgery (Conquest Research)
Orlando, Florida, United States
Cleveland Clinic Florida
Stuart, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Duly Health / NextStage Clinical Research
Naperville, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Abay Neuroscience Center / NextStage Clinical Research
Wichita, Kansas, United States
Louisiana Spine Institute
Shreveport, Louisiana, United States
Anne Arundel Medical Center (AAMC)
Annapolis, Maryland, United States
Lahey Medical Center
Burlington, Massachusetts, United States
Washington University St. Louis
St Louis, Missouri, United States
Mt. Sinai
New York, New York, United States
Montefiore
The Bronx, New York, United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States
Texas Back Institute
Plano, Texas, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Elite Pain and Spine Institute
Mesa, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STAND
Identifier Type: OTHER
Identifier Source: secondary_id
AGN-CIP-201
Identifier Type: -
Identifier Source: org_study_id
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