Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Modified Harris Hip Score
研究概览
简要总结
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available.
The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes.
Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.
详细描述
The purpose of the study is to perform a prospective multi-center study evaluating the feasibility of a knotless capsular closure device in patients undergoing primary hip arthroscopy.
All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form. All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions. All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form. The study participant will then sign and date the consent form, as well as the research staff obtaining consent. Consent can be withdrawn at any time the participant chooses either verbally or in writing.
Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device. These patients will follow up for two years with their providers and researchers, who will collect their patient-reported and clinical outcomes. Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a primary hip arthroscopy
- •Patients younger than 60 years old.
- •Patients who will receive capsular closure with the Arthrex LoopLocTM device following hip arthroscopy.
排除标准
- •Patients that had previous hip surgery,
- •Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees.
- •Patients that have a cartilage damage grade greater than or equal to 3.
结局指标
主要结局
Modified Harris Hip Score
时间窗: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
次要结局
- Hip Outcome Score Sports-Specific Subscale(2 years)
- Patient Satisfaction(2 years)
- Non-Arthritic Hip Score(2 years)
- International Hip Outcome Tool(2 years)
- Visual Analog Scale(2 years)