A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
研究概览
简要总结
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
详细描述
This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Prospective Cohort:
- •Scheduled to undergo ACL surgery with the BEAR Implant
- •Willing and able to provide informed consent
- •Willing and able to complete required follow-up visits and assessments
- •Inclusion Criteria for Retrospective Cohort:
- •1. Underwent ACL surgery with the BEAR Implant
排除标准
- •The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
- •Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
结局指标
主要结局
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
时间窗: 2 Years
This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
Knee laxity based on the Lachman test at 1 year
时间窗: 1 year
The Lachman will be performed during physical exam.
次要结局
- Marx Activity Score at 6, 9, 12 months and at 2 years after surgery(6 months thru 2 years)
- IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care(6-12 months)
- Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery(6 months thru 2 years)
- VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery(1 year)
- Current Status Questionnaire(2 years)
- Pain Medication Use(2 years)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery(6 months- 2 years post surgery)