Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 40
- 主要终点
- EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
研究概览
简要总结
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation.
Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subject requires Arthroscopic rotator cuff repair (ARCR);
- •Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.
排除标准
- •Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
- •Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
- •Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
结局指标
主要结局
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Quick DASH (Disabilities of Arm, Shoulder and Hand) is designed to measure physical function and symptoms. It assesses 11 items, with scores ranging from 0 to 100 where 0 indicates no disability (i.e., better outcome) and 100 indicates most severe disability (i.e., worse outcome).
Oxford Shoulder Score (OSS)
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Pain, Visual Analog Scale (VAS) Score
时间窗: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
Single Assessment Numeric Evaluation (SANE) Score
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Single Assessment Numeric Evaluation (SANE) is a simple but effective measure where patients rate their shoulder condition as a percentage (0-100%), where 100% being completely normal and 0% being the worst condition imaginable.
次要结局
- Post-operative Recovery: Sling Type and Mobilization Time(2 weeks)
- Retear Rate(3 months, 6 months, 12 months, and 24 months)
- Post-operative Recovery: Return to Work(Baseline and 6 months)