Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Device Survivorship
研究概览
简要总结
The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.
详细描述
This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:
- •Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- •Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment
- •Primary replacement after fracture of the radial head
- •Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.
排除标准
- •Infection
- •Osteomyelitis
- •Uncooperative patient or patient with neurological disorders who are incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- •Patient is known to be pregnant or breastfeeding.
- •Patient is unwilling to sign informed consent.
研究组 & 干预措施
ExploR Radial Head
Subjects who have received the ExploR Radial Head Device.
干预措施: ExploR Radial Head (Device)
结局指标
主要结局
Device Survivorship
时间窗: 10 years
Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.
Device Safety
时间窗: 10 years
Assessed by recording frequency of adverse events during the length of the study.
次要结局
- QuickDASH(1, 3, 5, 7, and 10 years)