S32.01 S32.02 S32.03 S32.04 S22.05 S22.06
Conditions
Sponsors
Nexilis AG
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion 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. Single vertebra fracture located between the 10th thoracic and 4th lumbar vertebra, both included, caused by a diagnosed or by a primary or secondary osteopenia / osteoporosis 5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan). 6. Single vertebra body fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including two short index-screws in the broken vertebra 7. All fractures where pedicle screws of the following type (that have been proven for appropriate functionality with the ISS) can be used: o DePuy Synthes, Expedium Viper2 CFX Polyschraube (diameter 6.0 mm) o Silony Medical, VERTICALE VPS-6255-KF1 (diameter 6.2 mm), o Medtronic, Horizon SOLERA MAS CC (diameter 6.5 mm), o ulrich medical, uCentrum (diameter 5.5-6.5 mm), o Medtronic, CD Horizon Legacy (Longitude) (diameter 6.5 mm) At the discretion of the investigator pedicle screws with lengths between 35 and 60 mm can be used.
Exclusion criteria
Exclusion criteria: Patient 1. Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 5 years before enrolment into the trial. 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) 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. kyphoplasty, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects will be monitored for (serious) adverse events and (serious) adverse device effects continuously during the study by the investigators. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Assessment of the correction loss of the bi-segmental kyphosis angle. The change in the bi-segmental kyphosis-angle will be measured to evaluate the construct stability. Comparison will be made between the postoperative x-ray at day 3 (± 1 day) and the x-rays 1, 3, 6, 12, 24 and 36 months, respectively. 2) Time of X-Ray exposure (accumulated duration; from skin incision to skin suture) of patients and medical personnel. 3) Compressions rate of the anterior vertebral body height measured in the lateral x-ray post-operatively at day 3 (± 1 day) compared to 1, 3, 6, 12, 24 and 36 months postoperatively. 4) Screw loosening measured following the method of Aghayev et al. (* Development and validation of a quantitative method to assess pedicle screw loosening in posterior spine nstrumentation on plain radiographs). Therefore, the angle between the axes of the pedicle screws and the cranial endplate are measured 1, 3, 6, 12, 24 and 36 months postoperatively. 5) Evaluation of the functional outcome with the Owestry Disability Index (ODI) before surgery, 1, 3, 6, 12, 24 and 36 months postoperatively. 6) Evaluation of the actual pain level with the Pain Scale as Visual Analogue Scale (VAS) before surgery, postoperatively at day 3 and 1, 3, 6, 12, 24 and 36 months postoperatively. 7) Evaluation of the clinical outcome with the SF-12 before surgery, 1, 3, 6, 12, 24 and 36 months postoperatively. 8) Treatment success at 6, 12, 24 and 36 months postoperatively (composite endpoint including the correction loss of the bi-segmental kyphosis angle, the ODI and the occurrence of any device-related serious adverse events). | — |
Countries
Germany
Contacts
Public ContactLeanna Caron
Nexilis AG
Outcome results
None listed