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

A maximum of 100 subjects will be treated at up to 10 study sites across Europe. Follow up visits will be conducted at 1 day, 1 month, 3 months, 12 months and 24 months after the procedure.

Study enrollment will occur in three stages:

Stage 1: 5 subjects to evaluate safety at 3 months Stage 2: 30 subjects to evaluate safety at 3 months Stage 3: 100 subjects to evaluate safety and performance at 12 months

Inclusion criteria

• Subject is a male or female 50 years of age or older at time of study treatment.
• Criterion omitted
• Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
• This VCF meets all of the following criteria:

• Fracture due to diagnosed or presumed underlying osteoporosis
• VCF from T1 to L5 inclusive
• Fracture age ≤6 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 50% based on X-ray at baseline.
• Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI, bone scan, CT, serial radiographs, or other imaging demonstrating acuity.
• 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 24 hours 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 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., 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.