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

Four hundred and 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).

• Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
• 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.

Inclusion criteria

• 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

Exclusion criteria

• 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).
• Subject has severe cardiopulmonary deficiencies.
• Subject has a Body Mass Index (BMI) > 35.
• Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
• Subject has a history of tuberculous spondylitis.
• 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.
• Subject is on oral or parenteral immune-suppressive drugs.
• Subject has uncontrolled diabetes mellitus.
• Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
• Subject has a diagnosed calcium metabolism disorder.
• Subject has known allergies to calcium-based bone void fillers.
• Subject is pregnant or planning to become pregnant during participation in the study.
• 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).
• Subject is currently enrolled in another interventional clinical study.