Zip Arthroplasty Patient Satisfaction Evaluation (ZAPS)
研究概览
详细说明
Sutures and metal staples are considered standard of care methods for surgical skin closure. The Zip® Surgical Skin Closure device from ZipLine Medical, Inc. (Campbell, CA USA) is a more recent method of skin closure that utilizes skin adhesive and adjustable ratcheting straps to achieve and maintain tension necessary for wound closure and healing. The Zip device was designated Class I, 510(k) Exempt by the US FDA in 2010, and the CE Mark was affixed in 2014.
Limited patient-reported satisfaction data exists for the Zip device as compared to staples and sutures, so this study will attempt to address this need.
The purpose of the study is to evaluate patient satisfaction of closure method used after knee joint arthroplasty. Metal staples and the Zip® Surgical Skin Closure device are approved methods in regular use. Selection of method is generally based on physician preference. This study is to determine what, if any, differences exist in patient satisfaction amongst the two methods
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Pennsylvania
-
Norristown、Pennsylvania、美国、194001
- Montgomery Orthopaedics Associates
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients undergoing primary elective knee arthroplasty.
- Willing and able to provide informed consent and/or obtain legal guardian authorization
- Willing and able to comply with the subject-specific requirements outlined in the study protocol
Exclusion Criteria:
- Patients that do not meet the conditions listed in the wound closure device warnings, precautions, and contraindications (Appendix A)
- Patients with comorbidities or conditions that the investigator deems to be ineligible for the study
- Patients without the capacity to give informed consent (e.g., dementia)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Zip Closure Device
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
|
Standard Knee Arthroplasty will be performed on study subjects.
The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|
Metal Staples
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
|
Standard Knee Arthroplasty will be performed on study subjects.
The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS)
大体时间：6 weeks post knee arthroplasty
|
The subject and investigator will rate commonly described scar characteristics from a patient and observers perspective Subject and Physician will rate overall opinion of scar to normal skin where 1-Normal to 10-Very Different
|
6 weeks post knee arthroplasty
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Satisfaction
大体时间：6 weeks post knee arthroplasty
|
Subject Experience and Satisfaction results at 6 weeks post procedure.
Subjects are asked of satisfaction with scar appearance on a scale of 1-minimal scar to 5-significant scar
|
6 weeks post knee arthroplasty
|
合作者和调查者
调查人员
- 首席研究员：Bruce Menkowitz, MD、Cheif of Surgery and Orthopaedics
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 011
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
膝关节置换术的临床试验
Knee Arthroplasty的临床试验
-
Archus Orthopedics, Inc.未知腰背疼痛 | 脊柱疾病 | 腰椎管狭窄症 | 椎管狭窄 | 腰椎滑脱 | 腿痛
-
Corin撤销类风湿关节炎 | 骨关节炎，膝盖 | 膝关节创伤后骨关节炎 | 内翻畸形，未另作分类，膝 | 外翻畸形，未另作分类，膝 | 屈曲畸形，膝关节 | 股骨远端骨折 | 胫骨上端骨折
-
Liberating Technologies, Inc.Hanger Clinic: Prosthetics & Orthotics招聘中膝盖以上的下肢截肢（受伤） | 截肢 | 假肢使用者 | 截肢；外伤性，腿部，下部 | 肢;缺席，先天性，较低 | 截肢；外伤性，腿部：大腿，臀部和膝盖之间美国
-
Liberating Technologies, Inc.Hanger Clinic: Prosthetics & Orthotics招聘中膝盖以上的下肢截肢（受伤） | 截肢 | 假肢使用者 | 截肢；外伤性，腿部，下部 | 肢;缺席，先天性，较低 | 截肢；外伤性，腿部：大腿，臀部和膝盖之间美国
-
University of AarhusAarhus University Hospital; Zimmer Biomet; Vejle Hospital主动，不招人