A Randomized Controlled Trial of the KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rates of extension deficit
研究概览
简要总结
The purpose of this study is to evaluate how well the KRONOS postoperative knee brace reduces pain and enhances recovery compared with the standard Breg T-scope hinged brace following anterior cruciate ligament (ACL) reconstruction knee surgery.
详细描述
The KRONOS postoperative unloader brace features a new bracing technology that combines the capability of hyperextension immobilization with additional benefits of offloading up to 60 lbs off the knee joint. The adjustable tensioning system in the KRONOS brace offers promising potential to significantly alleviate patient discomfort and pain, facilitate quicker return to a higher level of activity, and ultimately contribute to improved surgical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Subjects > 18 years of age
- •English-speaking
- •Scheduled to undergo primary anterior cruciate ligament reconstruction surgery
- •No history of prior knee surgery on the operative knee
- •No concomitant ligamentous repair or reconstruction procedures (i.e. ligamentous pathology aside from anterior cruciate ligament).
- •Subjects undergoing concurrent partial meniscectomy or meniscus repair that would not alter postoperative weight-bearing status or rehabilitation protocol would be eligible for inclusion.
- •Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear
排除标准
- •Age < 18 years of age
- •Non-English speaking
- •Revision ACL reconstruction
- •Multi-ligamentous injury, including concomitant posterior cruciate ligament, medial collateral ligament and fibular collateral ligament injuries
- •Concomitant meniscal or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- •Inability to comply with the proposed follow-up clinic visits
- •Subjects lacking decisional capacity
- •Worker's compensation subjects
- •Requiring a custom-sized brace
研究组 & 干预措施
Arm 1-Kronos brace
Subjects randomized to the treatment group will be measured and fitted with the KRONOS knee brace at their initial clinic visit after study enrollment.
干预措施: Arm 1-Kronos brace (Device)
Arm 2-Breg T-Scope brace
Subjects randomized to the standard postoperative Breg T-Scope hinged knee brace in the operating room that will be locked in full extension.
干预措施: Arm 2-Breg T-Scope brace (Device)
结局指标
主要结局
Rates of extension deficit
时间窗: 1 year post-operative
Rates of extension deficit (as measured by the fraction of patients with reduced extension compared to the contralateral determined by heel height and goniometric measurements of knee extension (cm/ degrees)
次要结局
未报告次要终点