Status:
TERMINATED
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Lead Sponsor:
Nexilis AG
Conditions:
Osteoporotic Fracture of Vertebra
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the ef...
Eligibility Criteria
Inclusion
- Patient
- Age ≥ 50 and ≤ 85, male and female patients
- Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
- 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
- Fractures between the 10th thoracic and 4th lumbar vertebra, both included
- Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan).
- Fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including kyphoplasty in the broken vertebra
- All fractures where pedicle screws can be used
Exclusion
- Patient
- Substance use disorders (incl. tobacco abuse \>20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
- BMI \> 35
- Permanent or progressive neurologic deficits (incl. upper motor neuron disease and myelopathy)
- Known Creutzfeldt Jacob Disease
- 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
- Rheumatoid arthritis or known disorders of bone metabolism (excl. osteopenia/osteoporosis, Vitamin D deficiency)
- Radiation therapy of the spine in medical history
- Contraindications to pedicle screw and rod stabilization
- 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).
- A compromised immune system or a therapy with systemic corticosteroids or immunosuppressants
- Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor) \<2 years ago from time of randomization
- Known allergy to any component of the investigational device
- History of severe allergy, anaphylactic reactions and hypersensitivity reactions experienced in previous surgical interventions.
- 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
- Participation in other clinical investigations for drugs or devices
- Fracture
- Fracture age \> 3 months
- Major surgery to the spine planned for at least 12 months following enrolment
- 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)
- Severe spinal deformations or fusion at the target vertebral or adjacent segments
- Previous operations at the spine in the target or adjacent vertebrae
- Infections or inflammatory processes at vertebral bodies
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04495439
Start Date
September 11 2019
End Date
October 25 2022
Last Update
February 9 2024
Active Locations (1)
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1
Dept. of Orthopaedics and Traumatology, Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020