NCT04495439终止不适用
Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-Screw Augmentation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nexilis AG
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change of the bi-segmental kyphosis angle (Correction Loss)
研究概览
简要总结
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 efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture.
The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
- •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 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
结局指标
主要结局
Change of the bi-segmental kyphosis angle (Correction Loss)
时间窗: Day 3 to 6 Months
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.
次要结局
- Compression rate(post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively)
- Screw loosening(up to 12 months)
- Treatment success(at 6 and 12 months postoperatively)
- Time of x-ray exposure(Surgery)
- Evaluation of the pain level(baseline, 3 months, 6 months, 12 months)
- Evaluation of the functional outcome with the Oswestry Disability(baseline, 3 months, 6 months, 12 months)
- Evaluation of the clinical outcome(baseline, 3 months, 6 months, 12 months)
研究者
研究点 (2)
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