RISE: Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment with AGN1 LOEP SV Kit VCF is treated with the AGN1 LOEP SV Kit |
Device: AGN1 LOEP SV Kit
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.
|
Outcome Measures
Primary Outcome Measures
- Change in Back Pain from Baseline [12 months]
Change in Back Pain at 12 months from Baseline as indicated by Visual Analogue Scale (VAS), measured on a continuous 100 mm line.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is a male or female ≥ 55 years of age at time of treatment.
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Subject is ≤ 85 years of age at time of treatment.
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Subject has only one (1) VCF. Note the adjacent level vertebral bodies
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This VCF meets all of the following criteria:
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Fracture due to diagnosed or presumed underlying osteoporosis
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VCF from T6 to L5 inclusive
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Fracture age < 3 months at time of treatment
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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.
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Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI or bone scan imaging.
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Subject has central pain upon palpation over the spinal process at the target vertebral body.
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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.
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Subject has an Oswestry Disability Index (ODI) score of ≥ 30%.
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Subject is capable of giving written informed consent to participate in the study.
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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:
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Target VCF is due to underlying or suspected tumor.
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Target VCF is due to high-energy trauma.
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Target VCF is diagnosed as an osteonecrotic fracture.
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Target VCF has segmental kyphosis of > 30°.
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Target VCF is unstable including split or burst fractures.
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Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).
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Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
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Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
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Subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
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Subject has spondylolisthesis > Grade 1 at target vertebral body.
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Subject has pain due to any other condition that requires daily narcotic medication.
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Subject has severe cardiopulmonary deficiencies.
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Subject has a bleeding disorder.
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Subject has a Body Mass Index (BMI) > 35.
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Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
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Subject has a history of tuberculosis spondylitis.
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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.
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Subject is on oral or parenteral immune-suppressive drugs.
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Subject has an active bone infection at target VCF.
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Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator.
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Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
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Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
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Subject has known allergies to calcium-based bone void fillers.
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Subject is pregnant or planning to become pregnant during participation in the study.
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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).
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Subject is currently enrolled in another interventional clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthopedic University Hospital Friedrichsheim | Frankfurt | Hessen | Germany | 60528 |
| 2 | Sana Klinikum Offenbach GmbH | Offenbach | Germany | ||
| 3 | Eila Rivera Boix | Barcelona | Spain |
Sponsors and Collaborators
- AgNovos Healthcare, LLC
Investigators
- Principal Investigator: Mohammad Arab Motlagh, MD, Sana Klinikum Offenbach GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AGN-CIP-200