STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
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
AgNovos Healthcare, LLC
408 participants
May 31, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria13
- 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 Criteria28
- 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.
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Interventions
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.
High viscosity PMMA bone cement will be used for vertebral augmentation.
Locations(19)
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NCT04835428