Effect of Internal Bracing on Outcomes Following ACL Reconstruction With Quadriceps Tendon: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation
研究概览
简要总结
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing.
详细描述
The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
排除标准
- •Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
- •History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
研究组 & 干预措施
Internal Brace
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
干预措施: Arthrex Internal Brace (Device)
Internal Brace
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
干预措施: ACL Reconstruction (Procedure)
Standard ACLR
Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
干预措施: ACL Reconstruction (Procedure)
结局指标
主要结局
Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation
时间窗: Baseline, Month 6 Post-Operation
The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation
时间窗: Baseline, Month 12 Post-Operation
Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation
时间窗: Baseline, Month 6 Post-Operation
Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.
Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation
时间窗: Baseline, Month 12 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation
时间窗: Baseline, Month 12 Post-Operation
The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation
时间窗: Baseline, Month 6 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
次要结局
未报告次要终点