NCT02394080已完成不适用
CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Normal Radiographic Fracture Healing
研究概览
简要总结
The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture-Specific Inclusion Criteria
- •Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 (The Netherlands); AO Classification 11A1, 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 and 13A1, 13A2 and 13B1, 13B2 (Germany).
- •Fracture is closed, Gustilo Type I or II.
- •General Inclusion Criteria
- •Skeletally mature men and women, 50 years of age or older (The Netherlands only) or 61 years of age or older (Germany only) at time of index injury.
- •a) Female patients of child bearing potential agree to use double barrier method of contraception (The Netherlands only) b) Female patients of non-child bearing potential must meet one of the following criteria (The Netherlands only):
- •Postmenopausal for at least 1 year, or
- •Documented oophorectomy or hysterectomy, or
- •Surgically sterile
- •Willing and able to understand and sign the informed consent.
- •Fracture-Specific
排除标准
- •Index treatment is greater than 28 days (The Netherlands only) or 14 days (Germany only) post fracture
- •Open fractures with severe contamination.
- •Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- •Marked bone loss or bone resorption patients, who due to a prior delayed union or non-union of the bones or other illnesses, may not be able to have their fracture adequately reduced prior to placement of the IlluminOss-device. This could leave bone void spaces that would preclude the device from maintaining alignment of the fractured bone.
- •Previous fracture of affected limb.
- •General Exclusion Criteria
- •Pregnant or lactating (The Netherlands only).
- •Patients with a contralateral fracture of the forearm or humerus (Germany only).
- •Active or incompletely treated infections that could involve the site where the device will be implanted.
- •Distant foci of infections that may spread to the implant site
- •Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder).
- •Concomitant metabolic disorders that may impair bone formation.
- •Osteomalacia.
- •Allergic to implant materials or dental glue.
- •Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
- •Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).
- •Life expectancy less than one year due to concurrent illness.
研究组 & 干预措施
Photodynamic Bone Stabilization System (PBSS)
Experimental
The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone.
干预措施: Photodynamic Bone Stabilization System (Device)
结局指标
主要结局
Normal Radiographic Fracture Healing
时间窗: 180 days
Two of four cortices or two of four views demonstrating bridging on standard radiographs
次要结局
- Evaluation of Complete Radiographic Healing(180 and 360 days)
- Evaluation of Normal Radiographic Healing(360 days)
- Summary of Pain VAS(180 and 360 days)
- Summary of DASH Score(180 and 360 days)
- Summary of Constant Shoulder Score(180 and 360 days)
- Summary of Pain on Palpation(180 and 360 days)
- Summary of Return to Pre-Fracture Mobility(180 and 360 days)
- Summary of Range of Motion(180 and 360 days)
- Summary of Disability Status(180 and 360 days)
研究者
研究点 (6)
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