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
- Quadriceps strength
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.
研究组 & 干预措施
ASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
干预措施: Educate patients on return to sports and the importance of quadriceps strength (Other)
ASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
干预措施: Anatomical single-bundle reconstruction（ASBR method） (Procedure)
ASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
干预措施: rehabilitation training protocol (Other)
CASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
干预措施: Central axial single-bundle reconstruction（CASBR group） (Procedure)
CASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
干预措施: rehabilitation training protocol (Other)
CASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
干预措施: Educate patients on return to sports and the importance of quadriceps strength (Other)
DB group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
干预措施: Double-bundle reconstruction （DBR method） (Procedure)
DB group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
干预措施: rehabilitation training protocol (Other)
DB group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
干预措施: Educate patients on return to sports and the importance of quadriceps strength (Other)
结局指标
主要结局
Quadriceps strength
时间窗: At 2 years after surgery
Side to side quadriceps strength assessed by Biodex arthrometer test
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.
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.
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.
次要结局
- BMI(At baseline)
- 6-m hop test(At 10 years after surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At 10 years after surgery)
- Tegner Score(At 10 years after surgery)
- Single-Legged Hop Test(At 10 years after surgery)
- Cross hop test(At 10 years after surgery)
- Gender(At baseline)
- Age(At baseline)
- 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)
- Triple hop test(At 10 years after surgery)
- Quadriceps strength(At 10 years after surgery)
- Lysholm score(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))
- 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)
- Single-Legged Hop Test(At 2 years after surgery)
- Single-Legged Hop Test(At 5 years after surgery)
- Triple hop test(At 2 years after surgery)
- Triple hop test(At 5 years after surgery)
- Cross hop test(At 2 years after surgery)
- Cross hop test(At 5 years after surgery)
- 6-m hop test(At 2 years after surgery)
- 6-m hop test(At 5 years after surgery)
- Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale(At 2 years after surgery)
- Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale(At 5 years after surgery)
- Knee laxity(At 5 years after surgery)
- Quadriceps strength(At 5 years after surgery)
- Lysholm score(At 2 years after surgery)
- Lysholm score(At 5 years after surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At 2 years after surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At 5 years after surgery)
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000(At 5 years after surgery)
- Tegner Score(At 2 years after surgery)
- Tegner Score(At 5 years after surgery)
- Magnetic resonance imaging (MRI)(At 5 years after surgery)
- Knee laxity （KT-2000 arthrometer）(At 5 years after surgery)
研究者
Yu Jiakuo
Clinical Professor
Peking University Third Hospital