A Prospective, Multi-Center Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)
研究概览
简要总结
The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Skeletally mature adult males and females 18 years of age or older.
- •Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
- •Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:
- •Postmenopausal for at least 1 year OR
- •Documented oophorectomy or hysterectomy
- •Surgically sterile OR
- •If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
- •Able to understand and provide informed consent.
- •Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
- •Impending Fracture-Specific Inclusion Criteria
- •Documented presence of solitary metastatic lesion.
- •Mirels Criteria Score ≥
- •Destruction of cortical bone at impending fracture site > 50%.
- •Actual Fracture-Specific Inclusion Criteria
- •Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B
- •Fracture is closed, Gustilo Type I or IIA.
排除标准
- •General Exclusion Criteria
- •Primary tumor (osteogenic origin, etc.) at site.
- •Impending fracture or actual fracture location other than humerus.
- •Current concomitant traumatic fracture of any other location.
- •Active or incompletely treated infections that could involve the device implant site.
- •Distant foci of infection that may spread to the implant site.
- •Allergy to implant materials or dental glue.
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.
- •Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
- •Impending Fracture-Specific Exclusion Criteria
- •Mirels Score <
- •Destruction of cortical bone at impending fracture site < 50%.
- •Prior surgery and/or prior fracture of affected site.
- •Any articular component to impending fracture site.
- •Actual Fracture-Specific Exclusion Criteria
- •Index treatment is greater than 28 days post fracture.
- •Open fractures with severe contamination.
- •Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- •Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
- •Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
研究组 & 干预措施
Photodynamic Bone Stabilization System (PBSS)
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
Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)
时间窗: 90 days
* No Serious Device Related Complications * No additional surgical interventions: revisions, supplements, fixations or removals
Functional Improvement (Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline)
时间窗: 90 days
* Barthel Index of Activities of Daily Living (ADLs) improvement of \> +10% from baseline * EORTC QLQ-C30 improvement of \> +10% from baseline * EORTC QLQ-BM22 improvement of \> +10% from baseline
Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)
时间窗: 90 days
No device fracture, migrations, mal-alignment or loss of reduction or fixation
Pain Reduction
时间窗: 90 days
VAS Pain Score change of \> -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score.
Functional Improvement - Barthel Index
时间窗: 90 days
Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome.
次要结局
- Functional Improvement (-Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline)(90, 180, 360 days)
- Disability status(90, 180, 360 days)
- Assessment of prescription and over-the-counter analgesic medication use(90, 180, 360 days)
- Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)(90, 180, 360 days)
- Pain Reduction (VAS Pain Score change of > -33% compared to baseline)(90, 180 and 360 days)
- Duration of index procedure and length of hospital stay(90, 180, 360 days)
- Evaluation of duration of physical therapy prescription(90, 180, 360 days)
- VAS Pain score from baseline through all follow-up intervals(90, 180, 360 days)
- Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)(90, 180, 360 days)
- Survivability from time of index procedure to death(90, 180, 360 days)
- Incidence and number of AEs(90, 180, 360 days)
- Incidence and number of procedure- and device-related complications(90, 180, 360 days)
- Activities of Daily Living score through all follow-up intervals(90, 180, 360 days)
- Device Status(90, 180, 360 days)
- Pain Reduction(180 and 360 days)
- Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score(90, 180, 360 days)
- Functional Improvement - Barthel Index(180 and 360 days)
- Change From Baseline of Barthel Index of Activities of Daily Living(90, 180, 360 Days)
- Functional Improvement - EORTC QLQ-C30(90, 180, 360 days)
- Functional Improvement - EORTC QLQ-BM22(90, 180, 360 days)
- Surgical Interventions(90, 180, 360 days)
- Serious Device-Related Complications(90, 180, 360 days)