Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 主要终点
- Magnetic resonance imaging (MRI) to assess graft healing
研究概览
简要总结
From June 1, 2016, to July 1, 2017, a total of 406 patients with ACL rupture were randomly assigned to three different ACL surgeries: anatomical single-bundle, central axial single-bundle and double-bundle. A prospective randomized cohort study was conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18-
- •ACL rupture confirmed by both physical examination and MRI.
- •Surgery done by senior doctor.
- •Using STG as autograft.
排除标准
- •With bilateral acl rupture.
- •Second injury.
- •Previous surgery in extremity.
结局指标
主要结局
Magnetic resonance imaging (MRI) to assess graft healing
时间窗: At 2 years after surgery
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Quadriceps strength
时间窗: At 2 years after surgery
Side to side quadriceps strength assessed by Biodex arthrometer test
Knee laxity （physical exam）
时间窗: At 2 years after surgery
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1\~2mm(0+), grade B: 3\~5mm (1+), grade C: 6\~10mm (2+) and D Grade: \>10mm(3+) assessed by Lachman test of physical examination.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
时间窗: At 2 years after surgery
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee laxity （KT-2000 arthrometer）
时间窗: At 2 years after surgery
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) \< - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) \> 5 mm. The back-pushing KT-2000 is also divided into side to side differences as (A) \< - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) \> 1 mm.
Magnetic resonance imaging (MRI)
时间窗: At 2 years after surgery
Magnetic resonance was used to calculate the graft bending angle (GBA), which is the angle between the intra-femoral graft and the intra-articular graft. GBA is associated with graft widening and graft healing.
次要结局
- Single-Legged Hop Test(At 10 years after surgery)
- Cross hop test(At 10 years after surgery)
- Gender(At baseline)
- Age(At baseline)
- 6-m hop test(At 10 years after surgery)
- Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale(At 10 years after surgery)
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000(At 10 years after surgery)
- Knee laxity(At 10 years after surgery)
- Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)(At 2 years after surgery)
- BMI(At baseline)
- Triple hop test(At 10 years after surgery)
- Quadriceps strength(At 10 years after surgery)
- Lysholm score(At 10 years after surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At 10 years after surgery)
- Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)(At 5 years after surgery)
- Computed tomography (CT)(At 1 days after surgery.(baseline))
- Tegner Score(At 10 years after surgery)
- Short Form (SF)-36,The medical outcome study 36-items short form health survey(At 10 years after surgery)
- Magnetic resonance imaging (MRI)(At 10 years after surgery)
- Knee laxity （KT-2000 arthrometer）(At 10 years after surgery)
研究者
Yu Jiakuo
Clinical Professor
Peking University Third Hospital