S32.01 S32.02 S32.03 S32.04 S22.01 S22.02 S22.03 S22.04 S22.05
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. 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 bisegmental 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 can be used: o DePuy Synthes EXP Viper2 CFX Polyschraube (diameter 6.0 mm) o VERTICALE Silony VPS-6255-KF1 (diameter 6.2 mm), o Medtronic SOLERA MAS CC (diameter 6.5 mm), o Ulrich medical uCentrum (diameter 5.5-6.5 mm), o Medtronic Longitude CD Horizon Longitude (diameter 6.5 mm)
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 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 semimalignant 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 |
|---|---|
| Correction loss of the bi-segmental kyphosis angle (non-inferiority ISS Sleeve vs. PMMA). The evaluation will be done from a comparison of plain x-rays taken post-operatively before discharge (day 3 (± 1 day)) and 6 months post operatively both in upright position. The correction loss of the bi-segmental kyphosis angle will be compared in the ISS Sleeve screw augmentation group and the standard PMMA screw augmentation group to show the non-inferiority concerning stability of the new system after 6 months. The non-inferiority margin is 5°. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time of X-Ray exposure (accumulated duration; from skin incision to skin suture) of patients and medical personnel. 2) Compressions rate of the anterior vertebral body height measured in the lateral x-ray post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively. 3) Screw loosening measured following the method of Aghayev et al. [1]. Therefore, the angle between the axes of the pedicle screws and the cranial endplate are measured postoperatively and 3, 6 and 12 months postoperatively. 4) Loss of correction. 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 before discharge (day 3 (± 1 day)) and the x-rays 3 and 12 months, respectively. 5) Evaluation of the functional outcome with the Owestry Disability Index (ODI) at randomisation, 3, 6 and 12 months postoperatively. 6) Evaluation of the actual pain level with the Pain Scale as Visual Analogue Scale (VAS) at randomization, postoperatively, 3, 6 and 12 months postoperatively. 7) Evaluation of the clinical outcome with the SF-12 at randomization, 3, 6 and 12 months postoperatively. 8) Treatment success at 6 and 12 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
Austria
Contacts
Public ContactLeanna Caron
Nexilis AG
Outcome results
None listed