Clinical trial: The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System (NCT03580434)

Eligibility criteria:
Inclusion Criteria :

          -  Adult male and female patients

          -  Treatment of vertebral compression fracture (type A.1, some A.2 and rarely A.3 Magerl
             classification)

          -  Due to osteoporosis or tumorous lesions,

          -  Located in the thoracic and/or lumbar spine from T9 to L5.

          -  One unique vertebral fracture to be treated with the device

          -  Pain > 4

          -  ASA > 5

          -  For osteoporotic patient, fail in conservative treatment (8 days of antalgic
             medication Level III) and recent fracture (less than 6 weeks).

        Exclusion Criteria:

          -  Unstable fractures or neoplasms with posterior involvement

          -  Nonmobile fractures

          -  Damages of the pedicles or posterior wall

          -  Less than one third of the original vertebral body height remaining

          -  Spinal canal stenosis (>20%)

          -  Neurologic signs or symptoms related to the compression fracture or impeding
             pathological fracture

          -  Patient clearly improving on conservative treatment

          -  Pregnancy, breastfeeding

          -  Any contra-indication / allergy to implant material or cement

          -  Any previous surgical treatment (material or cement) in the targeted vertebra

          -  Systemic infection or infection located in the spine

          -  Any medical condition including but not limited to anaemia, coagulation disorders,
             fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would
             preclude the patient from having surgery or would impede the benefit of surgery

          -  Patient under the age of majority
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? 1