Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Improvement in Function
研究概览
简要总结
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
详细描述
This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
- •Between 14 and 70 years old at the time of surgery.
- •Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
- •Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- •If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
- •International Knee Documentation Committee (IKDC)
- •Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
- •Patient-Reported Outcomes Measurement Information System (PROMIS-10)
- •Tegner Activity Scale (TAS)
- •Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
- •Positive diagnostic imaging by MRI at baseline indicating an ACL tear
排除标准
- •Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
- •Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
- •Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
- •Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
研究组 & 干预措施
BioBrace Augment Group
An anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft.
干预措施: Anterior cruciate ligament reconstruction with BioBrace® augmentation (Device)
BioBrace Augment Group
An anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft.
干预措施: Arthroscopic anterior cruciate ligament reconstruction (Procedure)
结局指标
主要结局
Improvement in Function
时间窗: 3 years post-op
Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.
Adverse Events
时间窗: Baseline, 6-months, 1-, 2-, and 3-years post-op
Evaluation of device-related adverse events
次要结局
- International Knee Documentation Committee (IKDC)(Baseline, 6 months, 1-, 2-years post-op)
- Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)(Baseline, 6 months, 1-, 2-, and 3-years post-op)
- Patient-Reported Outcomes Measurement Information System (PROMIS-10)(Baseline, 6 months, 1-, 2-, and 3-years post-op)
- Tegner Activity Scale (TAS)(Baseline, 6 months, 1-, 2-, and 3-years post-op)
- Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)(6 months, 1-, 2-, and 3-years post-op)
- Secondary Surgical Intervention(s)(6 months, 1-, 2-, and 3-years post-op)
- Re-tear Rate(6 months, 1-, 2-, and 3-years post-op)