Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Performance Patient Assessment
研究概览
简要总结
The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.
详细描述
The study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a PH Cage.
Specifically, the study will provide:
- Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.
- Assurance of continued product safety and effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 of at least legal age of consent according to applicable State Law.
- •Patient is able to understand and provide written consent
排除标准
- •The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
- •Pregnant female patients.
- •Patients with current or history of mental illness and/or senility.
- •Patients with current or history of alcoholism and/or chemical substance abuse.
- •Patient has a medical condition(s) that preclude cooperation with the rehabilitation regimen.
- •Patient has active infection at the operative site or other active systemic infection.
- •Patient has a pathologic proximal humerus fracture.
- •Patients proximal humerus fracture extends into the diaphysis.
- •Patient has associated glenohumeral dislocation.
- •Patient has known pre-existing rotator cuff disease.
- •Patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.
结局指标
主要结局
Primary Performance Patient Assessment
时间窗: Change from Baseline in Constant Murley Score at the 2 year post op
Constant Murley Score (CMS) The Constant Murley Score is a combination of visual analog scales assessing pain, activities of daily living and assessments of range of motion and strength using a long-armed goniometer and isometer. The higher the score the better for the following sections of the CMS: A. Pain (0-15 points) (e.g.15=no pain, 2=high pain), B. Everyday activities-question 1 (0-2 points) (e.g. 2=best, 0=worst), questions 2 and 3(0-4 points) (the higher the score the better), question 4 (0-10 points) C. Movement- questions 1 and 2 (0-20 points) (e.g. the greater the range of motion performed, the more points assigned), questions 3 and 4 (0-10 points) (e.g. points assigned based on movements performed) D. Strength (0-25 points) Score is calculated from the highest score of three attempts, with each score corresponding to the force in pounds (max 25 points) The overall score is then calculated by combining all sections (A+B+C+D= 0-100 points)
次要结局
未报告次要终点