An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty 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
- 20,000
- 试验地点
- 38
- 主要终点
- Constant
研究概览
简要总结
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
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 skeletelly mature
- •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, implantation should be delayed until infection is resolved
- •Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- •Medial humeral bone loss resulting in compromised humeral stem fixation
- •Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
- •Neuromuscular disorders that do not allow control of the joint
- •Significant 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 adversaly affect the function or longevity of the implant
- •Patient is pregnant
- •Patient is a prisoner
- •Patient is contraindicated for the surgery
- •Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
- •Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
- •Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
- •Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)
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
TESS (may be used as specific forms related to the pre-operative condition/diagnosis)
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
MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)
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
Oxford Score (may be used as an optional form for surgeons in the United Kingdom)
时间窗: Through study completion, an average of 1 per year
Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability
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
次要结局
未报告次要终点