Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in ACL-return to sport index (ACL-RSI) Scores
研究概览
简要总结
Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.
详细描述
Given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts, there might be a role for functional bracing following quadriceps ACL reconstruction. Additionally, no studies to date have assessed the role of psychological readiness of return to sport, kinesiophobia and return to sport rates with and without functional bracing following ACL reconstruction (ACLR).
The purpose of this randomized controlled trial is to assess the 2-year outcomes of psychological readiness, patient-reported outcome measures (PROMs), clinical stability, return to sport and failure rates following quadriceps autograft ACL reconstruction with and without functional bracing in the postoperative phase in younger athletic patients and military patients with a higher risk of failure or not returning to sports or duty, respectively, in a randomized study: the Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy trial (BRACE-trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with unilateral complete ACL injury
- •patients involved in sports and the desire to return to sports
- •patients undergoing quadriceps autograft ACL reconstruction
- •must be 14 to 39 years old
排除标准
- •multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
- •concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
- •concomitant femoral, tibial, or patellar fracture(s)
- •patients with significant osteoarthritis
- •concomitant ipsilateral knee dislocation or patellar dislocation
- •significant lower leg malalignment requiring correcting osteotomies
- •prior ACL surgery, including contralateral knee
- •pregnancy during injury or surgery
- •unable to provide consent
- •prolonged use of prednisolone or cytostatics
- •comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation
研究组 & 干预措施
With postoperative brace (DonJoy Defiance Pro)
Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace
干预措施: post-surgical functional bracing (Device)
Without post-surgical functional bracing
Quadriceps Autograft ACL Reconstruction without the use of post-surgical functional bracing
结局指标
主要结局
Change in ACL-return to sport index (ACL-RSI) Scores
时间窗: Baseline and 3, 6, 12, and 24 months
The ACL-Return to Sport after Injury scale (ACL-RSI) is a 12-item survey that measures psychological readiness to return to sport after an ACL injury or surgery. It uses a visual analog scale from 0 to 100, where higher scores indicate greater psychological readiness. The total score is calculated as a percentage of the 12-item total score. A higher ACL-RSI score indicates a greater level of psychological readiness for returning to sport.
次要结局
- Lachmeter(Baseline and Months 3, 6, 12, and 24)
- Lachman pivot shift(Baseline and 3, 6, 12, and 24 months)
- Lachman anterior drawer(Baseline and 3, 6, 12, and 24 months)
- Tegner Activity Score(Baseline and 3, 6, 12, and 24 months)
- Time to Return to Sport/Previous Activity Level(Months 3, 6, 12, and 24)
- Y-Balance Distance(Months 6, 12, and 24)
- Number of Single Hop(Months 6, 12, and 24)
- Number of Triple Hops(Months 6, 12, and 24)
- Number of Brace Complications(Months 6, 12, and 24)
- Tampa Scale Kinesiophobia 11 (TSK-11) Score(Baseline and 3, 6, 12, and 24 months)
- International Knee Documentation Committee (IKDC) Score(Baseline and 3, 6, 12, and 24 months)
- Lysholm score(Baseline and 3, 6, 12, and 24 months)
- Forgotten Joint Score (FJS-12)(Baseline and 3, 6, 12, and 24 months)
- SANE Score(Baseline and 3, 6, 12, and 24 months)
- 5-point Likert Scale for Surgery Satisfaction Score(Baseline and 3, 6, 12, and 24 months)
- Pain Visual Analog Scale (Pain - VAS) Score(Baseline and 3, 6, 12, and 24 months)
- Biodex Strength Testing(Months 6, 12, and 24)
- Reoperation Rate(Months 3, 6, 12, and 24)
- Failure Rate(Months 3, 6, 12, and 24)
- Brace Compliance Rate(Months 6, 12, and 24)