Shoulder Innovations Clinical Data Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 15
- 主要终点
- Durability of the device component implant
研究概览
简要总结
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
详细描述
The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.
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
- •At least 18 years of age.
- •Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
- •Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
- •Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
- •Willing and able to comply with the requirements of the study protocol
排除标准
- •Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
- •Incarceration.
- •Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
结局指标
主要结局
Durability of the device component implant
时间窗: From the implant procedure until 10 years post-operatively
Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery.
次要结局
- Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline(From baseline (pre-operatively) until 10 years post-operatively)
- Change in ASES score post-operatively at specified timepoints as compared to baseline(From baseline (pre-operatively) until 10 years post-operatively)
- Change in SANE score post-operatively at specified timepoints as compared to baseline(From baseline (pre-operatively) until 10 years post-operatively)
- Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline(From baseline (per-operatively) until 10 years post-operatively)
- Evaluation of radiographic images for radiolucent lines, implant stability and loosening(From baseline (pre-operatively) until 10 years post-operatively)
- Rate of intra-operative and post-operative adverse device effects (ADEs)/complications(From the implant procedure until 10 years post-operatively)