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
- 已完成
- 入组人数
- 81
- 试验地点
- 13
- 主要终点
- Change in Function
研究概览
简要总结
This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.
详细描述
This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.
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
- •Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
- •Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
- •VAS Pain Score > 60mm on 100mm scale.
- •Impending Fracture-Specific Inclusion Criteria
- •Documented presence of at least one metastatic lesion of the humerus.
- •Mirels Criteria Score ≥
- •(specific to the target humeral lesion and subject to minimum VAS score requirements)
- •Destruction of cortical bone at impending fracture site > 50%.
- •Actual Fracture-Specific Inclusion Criteria
- •Fracture is closed, Gustilo Type I or II.
排除标准
- •General Exclusion Criteria
- •Primary tumor (osteogenic origin, etc.) at site.
- •Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
- •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.
- •In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
- •In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
- •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 < 8 (specific to target humeral lesion).
- •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
- •Open fractures with severe contamination.
- •Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- •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
Photodynamic Bone Stabilization System (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
Change in Function
时间窗: Baseline and 90 days
Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Change in Pain
时间窗: Baseline and 90 days
Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).
Summary of Clinical Safety Success
时间窗: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360
No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation
次要结局
- Summary of Procedure and Device-Related Complications Rate(up to day 90, up to day180 since day 90, up to 360 since day 180)
- MSTS Upper Extremity Functional Outcome(90, 180, 360 days)
- Assessment of Post-Surgery Status(Surgery & Discharge, 7-14, 30, 90, 180, 360 days)
- Activities of Daily Living Score Through All Follow-up Intervals(Baseline, 90, 180 and 360 days)
- Summary of Change From Baseline Range of Motion by Visit and Test(Baseline, 90, 180 and 360 Days)
- Pain at Palpation(90, 180 and 360 days)
- Duration of Index Procedure(1 Day)
- Length of Hospital Stay(From day of procedure until the day of hospital discharge (up to 36 days))