RECRUITING

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

Conditions

Vertebral Compression Fracture Compression Fracture Vertebral Compression LOEP AGN1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-31

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04835428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is a male or female 50 years of age or older at the time of study treatment. 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	1. At least one of the target VCF(s) is unstable, including split or burst fracture. 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.

Inclusion Criteria

Exclusion Criteria

1. Subject is a male or female 50 years of age or older at the time of study treatment.
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

1. At least one of the target VCF(s) is unstable, including split or burst fracture.
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.

Contacts and Locations

Study Contact

Allison Gorman

CONTACT

2407536424

agorman@agnovos.com

Principal Investigator

Kern Singh

PRINCIPAL_INVESTIGATOR

Midwest Orthopedics at Rush

Study Locations (Sites)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235

United States

Elite Pain and Spine Institute

Mesa, Arizona, 85203

United States

Mayo Clinic

Phoenix, Arizona, 85054

United States

GW Medical Faculty Associates

Washington, District of Columbia, 20037

United States

Orlando Neurosurgery (Conquest Research)

Orlando, Florida, 32804

United States

Cleveland Clinic Florida

Stuart, Florida, 34994

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

NorthShore University HealthSystem

Evanston, Illinois, 60201

United States

Duly Health / NextStage Clinical Research

Naperville, Illinois, 60564

United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160

United States

Abay Neuroscience Center / NextStage Clinical Research

Wichita, Kansas, 67226

United States

Louisiana Spine Institute

Shreveport, Louisiana, 71101

United States

Anne Arundel Medical Center (AAMC)

Annapolis, Maryland, 21401

United States

Lahey Medical Center

Burlington, Massachusetts, 01805

United States

Washington University St. Louis

St Louis, Missouri, 63130

United States

Montefiore

Bronx, New York, 10467

United States

Mt. Sinai

New York, New York, 10029

United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374

United States

Texas Back Institute

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: AgNovos Healthcare, LLC

Kern Singh, PRINCIPAL_INVESTIGATOR, Midwest Orthopedics at Rush

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-31

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-05-31

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

LOEP
AGN1

Additional Relevant MeSH Terms

Vertebral Compression Fracture
Compression Fracture
Vertebral Compression