A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 10
- 主要终点
- Re-operation
研究概览
简要总结
This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
详细描述
The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.
A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.
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
- •Patient must be 18 years of age or older.
- •Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
- •Patients with failed conservative treatment within 3 weeks since injury.
- •Patient must be able and willing to complete the protocol required follow-up.
- •Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
- •Patient must be in a good nutritional state
排除标准
- •Delay of surgery for more than 3 weeks.
- •Tumor induced fractures
- •Patient is a prisoner.
- •Pregnancy/ breast feeding
- •Patient is a current alcohol or drug abuser.
- •Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
- •Patient has an active infection.
- •Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
- •Patient is sensitive to foreign body material.
研究组 & 干预措施
Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.
Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System.
Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.
干预措施: A.L.P.S. Proximal Humerus Plating System (Device)
结局指标
主要结局
Re-operation
时间窗: 1 year
Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function.
次要结局
- Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire(2 years)
- Clinical performance of the device is assessed using x-ray capture(2 years)
- Shoulder range of motion measurement(2 years)