Clinical trial: Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures (NCT04835428)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is between 55 and 85 years of age at time of study treatment.

          2. Subject has only one (1) acute VCF. Note that subjects are eligible if they have an
             asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level.

          3. The acute VCF meets all of the following criteria:

               1. Due to diagnosed or presumed underlying osteoporosis

               2. T1 to L5 inclusively

               3. Target VCF-related pain < 12 weeks at time of study treatment

          4. Target VCF shows loss of height of the vertebral body ≤ 40% based on X-ray at
             baseline.

          5. Pedicles for access to the target VCF have diameters that are ≥ 4 mm.

          6. 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.

          7. Focal tenderness to palpation of the spinal process of the target VCF on the physical
             exam correlates with imaging.

          8. 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 2 to 6 weeks of conservative
             care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care.

          9. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.

         10. Subject is capable of giving written informed consent to participate in the study.

         11. 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:

          1. Target VCF is unstable, including split or burst fracture.

          2. Subject has a bleeding disorder.

          3. Subject has an active infection of the spine or has an infection being actively
             treated with antibiotics.

          4. Target VCF is due to underlying or suspected tumor.

          5. Target VCF is due to high-energy trauma.

          6. Target VCF is due to osteonecrosis.

          7. Target VCF has a local kyphotic angle of > 30 degrees, measured as the angle between
             the superior endplate and inferior endplate at the target VCF.

          8. Subject has had any prior surgical treatment at the target vertebral level or adjacent
             vertebral levels.

          9. Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.

         10. Subject has spinal canal compromise causing clinical manifestations of cord, neural
             foramen, or nerve root compression at the level to be treated.

         11. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus
             or spinal stenosis.

         12. Subject has spondylolisthesis > Grade 1 at target vertebral body.

         13. Subject requires daily opioid medication for pain not related to the target VCF.

         14. Subject has severe cardiopulmonary deficiencies.

         15. Subject has a Body Mass Index (BMI) > 35.

         16. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's
             disease, renal osteodystrophy, or osteomalacia).

         17. Subject has a history of tuberculous spondylitis.

         18. 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.

         19. Subject is on oral or parenteral immune-suppressive drugs.

         20. Subject has uncontrolled diabetes mellitus.

         21. Subject has severe renal insufficiency defined as an estimated glomerular filtration
             rate (eGFR) < 30 mL/min.

         22. Subject has abnormal albumin-corrected serum calcium levels or a calcium metabolism
             disorder (e.g., hypercalcemia).

         23. Subject has known allergies to calcium-based bone void fillers.

         24. Subject is pregnant or planning to become pregnant during participation in the study.

         25. In the judgment of the Investigator, the subject is not a good study candidate.

         26. Subject is currently enrolled in another interventional clinical study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment