NCT03519555已完成不适用
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Graft fixation survival
研究概览
简要总结
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
详细描述
This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following:
Knee repair:
- ACL repair Posterior cruciate ligament (PCL) repair
- Extra-capsular repairs
- Medial collateral ligament (MCL)
- Lateral collateral ligament (LCL)
- Posterior oblique ligament (POL)
- Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
- Iliotibial band tenodesis
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
- •Subject has provided informed consent for study participation.
- •Subject is eighteen (18) years of age or older at the time of enrollment in the study.
- •Subject requires one of the following knee procedures:
- •Anterior cruciate ligament (ACL) repair
- •Posterior cruciate ligament (PCL) repair
- •Extra-capsular repair - Medial collateral ligament (MCL), Lateral collateral ligament (LCL), Posterior oblique ligament (POL)
- •Patellar realignment and tendon repair Vastus medialis obliquus advancement Iliotibial band tenodesis
- •Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.
排除标准
- •Subject has Body Mass Index (BMI) >
- •Subject has had total knee arthroplasty (TKA) in the study knee.
- •Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- •Subject has a known allergy to the study device or any of its components.
- •Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
- •Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
- •Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
结局指标
主要结局
Graft fixation survival
时间窗: 6 months
Survival rate at 6 months
次要结局
- Quality of Life - International Knee Documentation Committee Score(Pre-Op, 6 months and 12 months)
- Quality of Life - Tegner Activity Scale(Pre-Op, 6 months and 12 months)
- Quality of Life - EQ-5D-5L(Pre-Op, 6 months and 12 months)
- Quality of Life - Lysholm Score(Pre-Op, 6 months and 12 months)
- Graft fixation survival(12 months)
- Graft survival at 6 and 12 months(6 months and 12 months)
研究者
研究点 (3)
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