An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Sane Score
研究概览
简要总结
The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
- •Patient is willing to participate by complying with pre- and postoperative visit requirements
- •Patient is willing to agree to be followed for up to 10 years following their index surgery
- •Patient is willing and able to review and sign a study informed consent form
排除标准
- •Osteomyelitis of the proximal humerus or scapula
- •Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- •Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
- •The patient is unwilling or unable to comply with the post-operative care instructions
- •Alcohol, drug, or other subtance abuse
- •Any disease state that could adversaly affect the function or longevity of the implant
- •Patient is pregnant
- •Patient is a prisoner
- •Patient has a physical or mental condition that would invalidate the results
结局指标
主要结局
Sane Score
时间窗: Through study completion, an average of 1 per year
Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal
ASES
时间窗: Through study completion, an average of 1 per year
American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
Quick DASH
时间窗: Through study completion, an average of 1 per year
Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable
Smart Score
时间窗: Through study completion, an average of 1 per year
Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score
次要结局
未报告次要终点