Clinical trial: Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures (NCT04495439)

Eligibility criteria:
Inclusion Criteria:

        Patient

          1. Age ≥ 50 and ≤ 85, male and female patients

          2. Subject is able to understand the risks and benefits of participating in the study and
             is willing to provide written informed consent.

          3. Psychosocially, mentally and physically able to fully comply with the protocol
             requirements for the duration of the study including adhering to scheduled visits,
             treatment plan, completing forms and other study procedures.

             Fracture

          4. Fractures between the 10th thoracic and 4th lumbar vertebra, both included

          5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment
             of the screening qCT scan).

          6. Fractures with the indication and possibility for augmented bi-segmental dorsal
             pedicle screw and rod stabilization including kyphoplasty in the broken vertebra

          7. All fractures where pedicle screws can be used

        Exclusion Criteria:

        Patient

          1. Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse
             disorders within the last 2 years before randomization.

          2. BMI > 35

          3. Permanent or progressive neurologic deficits (incl. upper motor neuron disease and
             myelopathy)

          4. Known Creutzfeldt Jacob Disease

          5. Systemic infections:

               -  Known infection with human immunodeficiency virus (HIV) or, hepatitis B or C
                  requiring treatment

               -  Any active infection requiring the use of parenteral anti-microbial agents or
                  that is > grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version
                  4.03

          6. Rheumatoid arthritis or known disorders of bone metabolism (excl.
             osteopenia/osteoporosis, Vitamin D deficiency)

          7. Radiation therapy of the spine in medical history

          8. Contraindications to pedicle screw and rod stabilization

          9. Breast feeding, pregnancy or child-bearing potential (female patients of childbearing
             potential and male patients with a partner of child bearing potential must agree to
             use a highly effective contraceptive method).

         10. A compromised immune system or a therapy with systemic corticosteroids or
             immunosuppressants

         11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor)
             <2 years ago from time of randomization

         12. Known allergy to any component of the investigational device

         13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions
             experienced in previous surgical interventions.

         14. Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently
             treated diabetes (HbA1c > 8 %), active or uncontrolled infection) that could cause
             unacceptable safety risks or compromise compliance with the protocol

         15. Participation in other clinical investigations for drugs or devices

             Fracture

         16. Fracture age > 3 months

         17. Major surgery to the spine planned for at least 12 months following enrolment

         18. Any treatment of the fracture other than that specified in the inclusion criteria
             (e.g. index screws in the fractured vertebra, vertebroplasty, additional ventral
             stabilization)

         19. Severe spinal deformations or fusion at the target vertebral or adjacent segments

         20. Previous operations at the spine in the target or adjacent vertebrae

         21. Infections or inflammatory processes at vertebral bodies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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