Elbow Outcomes Clinical Study (WELBOW)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- Clinical Assessment: QuickDASH questionnaire
研究概览
简要总结
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).
详细描述
WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF). Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR) and Clinical Evaluation Report (CER) on Elbow system devices and support peer-reviewed publications on long-term product performance and safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of the informed consent or the non-opposition (when applicable).
- •Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
- •Willing and able to comply with the requirements of the study protocol.
- •For prospective inclusion: Considered for treatment with one Wright Medical Elbow arthroplasty or fracture devices included in this study (primary or revision).
- •For ambispective inclusion
- •Must have undergone an Elbow arthroplasty or fracture with one Wright Medical Elbow studied device between the date of the first Site Initiation Visit (SIV) and until 4.5 years prior this one in order to have at least the 5 years follow-up visit prospectively. Ambispective patients who were explanted prior the date of the first SIV will be included.
- •Must have complete Information available for each completed visit (demographics, preoperative information, surgery information, device details)*.
排除标准
- •Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
- •Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm).
- •Patient with previous elbow device(s) which remain(s) implanted.
结局指标
主要结局
Clinical Assessment: QuickDASH questionnaire
时间窗: At 24 months
Demonstrate a superior (lower) Total QuickDASH score average at 24 months postoperative compared to the upper threshold of 49 points The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability).
次要结局
- Implant Survivorship(At 2, 5, 7 and 10 years.)
- Clinical Assessment: QuickDASH questionnaire(From Baseline to 10 years except 7 years.)
- Safety and Tolerability : Number of device associated and procedure associated adverse events.(Up to 10 years.)
- Clinical Assessment: MEPS questionnaire(From Baseline to 10 years except 7 years.)
- Clinical Assessment: Range of Motion(From Baseline to 10 years except 7 years.)
- Clinical Assessment: Patient's Satisfaction(From Baseline to 10 years except 7 years.)
- Clinical Assessment: Strength(From Baseline to 10 years except 7 years.)
- Radiologic Assessment for bone characteristics(Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.)
- Radiologic Assessment for device migration(Before surgery, at 3 months for Osteosynthesis and 1, 2, 5 and 10 years for Arthroplasties.)