Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Skeletal Dynamics, LLC
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Recurrent Dislocations
概览
简要总结
The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is \>21 years of age.
- •The subject is considered a candidate for the Internal Joint Stabilizer -Elbow (IJS-E) under one of the following indications:
- •Subjects where either the elbow sublocates or dislocates after repairing the injured ligaments and/or bones
- •The elbow has been subluxated or dislocated for more than 10 days prior to surgery
- •The elbow subluxes or dislocates after surgical repair/reconstruction
- •The subject has sufficient quantity or quality of bone. Specifically there is sufficient trochlea of the distal humerus and of sufficient quality that the axis pin of the IJS-E has a secure hold as judged by the surgeon intra-operatively. Also, the screws placed in the ulna must be judged by the surgeon to have sufficient hold.
- •The subject or legal guardian has been informed of the nature of the study, agrees to its provisions, and has provided informed written consent.
- •The subject is willing to be available for the appropriate follow-up for the duration of the study.
排除标准
- •The subject has one of the following conditions:
- •Presents with limited elbow motion as opposed to instability (subjects where instability is created through surgical release for chronic limitation of movement, soft tissue release, removal of adhesions and heterotopic ossification and/or fascial interposition will be excluded).
- •Active infection, suspicion of colonization or quiescent infection
- •Bacteremia
- •Bone loss greater than 30% of the total articulation or involving an entire column of the distal humerus
- •The subject has less than 50% of the height of the coronoid remaining, based on lateral x-ray view
- •Osteoporosis to the degree that the screws that insert into the ulna loosen during implantation
- •Material sensitivity to titanium or cobalt chrome
- •The subject has imminent, known issues related to life expectancy.
- •The subject is unable and/or unwilling to cooperate with study procedures, a rehabilitative program, or required follow-up visits.
结局指标
主要结局
Recurrent Dislocations
时间窗: 8 months (6 month post-explant)
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E.
Broberg Morrey Functional Rating
时间窗: Eight months (6 months post-explant)
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better.
次要结局
未报告次要终点