An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- SST-12
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 Humeral Reconstruction Prosthesis in shoulder arthroplasty 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 for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
- •Patient is at least 21 years of age
- •Patient is expected to survive at least 2 years beyond surgery
- •Patient is willing to participate by complying with pre- and postoperative visit requirements
- •Patient is willing and able to read and sign a study informed consent form
排除标准
- •Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
- •Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- •Neuromuscular disorders that do not allow control of the joint
- •SIgnigicant injury to the brachial plexus
- •Non-functional deltoid muscles
- •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 adversely 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
SST-12
时间窗: Through study completion, an average of 1 per year
Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%
SPADI
时间窗: Through study completion, an average of 1 per year
Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities
Constant
时间窗: Through study completion, an average of 1 per year
Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
UCLA
时间窗: Through study completion, an average of 1 per year
University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes
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
MSTS
时间窗: Through study completion, an average of 1 per year
Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score
TESS
时间窗: Through study completion, an average of 1 per year
Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
次要结局
未报告次要终点