Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 417
- 试验地点
- 4
- 主要终点
- Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)
研究概览
简要总结
HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.
详细描述
The objective of this multicenter study is to collect preoperative, intraoperative, intermediate (approx. 2 years), mid-term (approx. 5 years), and long-term (approx. 10 years) postoperative data, on related clinical complications and clinical outcomes on the Sponsors market-approved hand and wrist Pyrocarbon implants, to demonstrate safety and performance of these implants in a real-world setting.
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 he/she receives the information and signs the informed consent (when applicable as per local regulatory requirements),
- •Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee,
- •Willing and able to comply with the requirements of the study protocol,
- •For prospective inclusion: considered for treatment with one of PyC Hand/Wrist study implants (primary or revision surgery),
- •For "ambispective" inclusion: must have undergone a Hand or Wrist arthroplasty with a PyC Hand/Wrist study implant before the date of first site initiation visit,
- •Follow-up visits (at least the last two) must be prospective,
- •Patient must have complete information available for each completed visit
排除标准
- •Patient pertaining to one of the categories referred to as "vulnerable population" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as "particularly vulnerable persons" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA),
- •Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times),
- •Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)
结局指标
主要结局
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)
时间窗: 24 months
Demonstrate a superior (lower) total QuickDASH average by 24 months postoperatively compared to the predefined Minimal Clinically Important Difference (MCID) upper threshold of 36 points. QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).
次要结局
- Clinical assessment: change from baseline in Strength score(up to 10 years)
- Change from baseline in Patient Satisfaction scores(up to 10 years)
- Safety evaluation(up to 10 years)
- Implant Survivorship(up to 10 years)
- Clinical assessment: change from baseline in QuickDash score(up to 10 years)
- Clinical assessment: change from baseline in Mobility score(up to 10 years)
- Clinical assessment: change from baseline in PRWE score(up to 10 years)