A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 3
- 主要终点
- Constant
研究概览
简要总结
The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques. The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes. Long-term follow-up to 10 years with minimum 2 year follow-up for patients.
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 at least 21 years of age at the time of surgery
- •Patient is indicated for reverse shoulder arthroplasty
- •Patient is willing to participate by complying with pre- and postoperative visit requirements
- •Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)
- •Patient is willing and able to review and sign a study informed consent form
- •Preop CT scan is within 3 months of the date of surgery
排除标准
- •Revision shoulder arthroplasty
- •Reverse shoulder arthroplasty for fracture
- •Need for structural glenoid bone graft
- •Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation 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
- •Significant injury to the brachial plexus
- •Non-functional deltoid muscles
- •The patient is unwilling or unable to comply with the post-operative care instructions
- •Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.
- •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 who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims
结局指标
主要结局
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
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
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
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
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%
次要结局
未报告次要终点