First-in-Human Study to evaluate Safety, Feasibility and preliminary Efficacy of the new ISS Sleeve Augmentation Technique in the Treatment of osteoporotic/osteopenic vertebral Fractures in the thoracolumbar Spine.
- Conditions
- S32.01S32.02S32.03S32.04S22.05S22.06
- Registration Number
- DRKS00017502
- Lead Sponsor
- exilis AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 2
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.
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) < 5 years ago from time of enrolment into the trial
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. 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjects will be monitored for (serious) adverse events and (serious) adverse device effects continuously during the study by the investigators.
- Secondary Outcome Measures
Name Time Method