RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

Study Overview
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Brief Summary
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This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.

Official Title
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A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)

Conditions
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Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture

Intervention / Treatment
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* Device: AGN1 LOEP SV Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or female ≥ 55 years of age at time of treatment. Subject is ≤ 85 years of age at time of treatment. Subject has only one (1) VCF. Note the adjacent level vertebral bodies This VCF meets all of the following criteria: Fracture due to diagnosed or presumed underlying osteoporosis VCF from T6 to L5 inclusive Fracture age < 3 months at time of treatment Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 40% based on X-ray at baseline. Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI or bone scan imaging. Subject has central pain upon palpation over the spinal process at the target vertebral body. Subject has failed conservative medical therapy, defined as either having a VAS back pain score of ≥ 70 mm after 2 to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after 6 weeks of conservative care. Subject has an Oswestry Disability Index (ODI) score of ≥ 30%. 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: Target VCF is due to underlying or suspected tumor. Target VCF is due to high-energy trauma. Target VCF is diagnosed as an osteonecrotic fracture. Target VCF has segmental kyphosis of > 30°. Target VCF is unstable including split or burst fractures. Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF). Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF. 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 based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis). Subject has spondylolisthesis > Grade 1 at target vertebral body. Subject has pain due to any other condition that requires daily narcotic medication. Subject has severe cardiopulmonary deficiencies. Subject has a bleeding disorder. 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 tuberculosis spondylitis. Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for five (5) years. Subject is on oral or parenteral immune-suppressive drugs. Subject has an active bone infection at target VCF. Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia). 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., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues). Subject is currently enrolled in another interventional clinical study.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with AGN1 LOEP SV Kit<br>VCF is treated with the AGN1 LOEP SV Kit | Device: AGN1 LOEP SV Kit<br>* The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Back Pain from Baseline | Change in Back Pain at 12 months from Baseline as indicated by Visual Analogue Scale (VAS), measured on a continuous 100 mm line. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOEP, AGN1