RetroBRACE II: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction - Considering Socioeconomic Aspects and Return to Work
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Range of Motion (ROM) of the knee
研究概览
简要总结
The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.
详细描述
Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.
The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest 2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients: 2 years since ACL reconstruction with autologous hamstring tendon
- •Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee
排除标准
- •BMI > 35 kg / m2
- •neuromuscular diseases that affect lower limb movement
- •Inability to give informed consent
- •Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee
结局指标
主要结局
Range of Motion (ROM) of the knee
时间窗: at baseline (2 years after surgery)
Range of Motion (ROM) of the knee
Postural stability
时间窗: at baseline (2 years after surgery)
The stability of posture and balancing will be determined by the variability of movement in the horizontal plane and the length of the pressure line during two 30-second single- leg stands (on solid surface and on foam surface) on a force plate (Kistler 9260AA6, Kistler AG, Winterthur, Switzerland; sampling frequency, 2400 Hz) and mathematical calculations
Proprioception (joint position sense)
时间窗: approx. 30 minutes at baseline (2 years after surgery)
Proprioception will be measured bilaterally with a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) using an active joint position sense protocol. The participants will be positioned on the dynamometer with knee and hip angles of 90°. They will then actively stretch their knees up to target angles of 60° or 30° flexion. Subjects will be asked to remember this position and then stretch their knees from a starting position of 90° flexion and, as soon as they think they have reached the target angle, push a stop button. The deviation between the perceived angle and the actual target angle will be calculated.
Gait analysis
时间窗: approx. 60 minutes at baseline (2 years after surgery)
Gait analysis performed on a treadmill with an integrated pressure plate and a walkway with two integrated force plates. Kinematic and EMG data collected using a 9-camera Vicon system and a 12-channel EMG system. To measure 3D joint angles, reflective markers will be attached to defined anatomical locations on the pelvis and legs.10 Bipolar surface electrodes will be attached bilaterally to the glutaeus medius, vastus medialis and lateralis, semitendinosus, tibialis anterior and gastrocnemius medialis muscles according to the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Study participants walk at self-selected speed. In addition, patients walk on treadmill at a self-selected speed, at a speed of 1.2 m/s and to run at self-selected speed and if possible at 2.2m/s. Kinematic and kinetic, EMG and pressure data recorded for all testing conditions.
Isokinetic muscle strength
时间窗: approx. 30 minutes at baseline (2 years after surgery)
Isokinetic muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). The maximum isokinetic flexion and extension torques will be measured on the knee between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum torques will be recorded for each direction of movement and normalized to body weight.
Functional activity score to determine the ability "return to activity"
时间窗: at baseline (2 years after surgery)
Functional activity tests include the Y-balance test, single-leg jump for distance, side jumps for time (30 seconds) and precision over a distance of 40 cm (side hop). The quantity of movement of these functional scores will be calculated.
次要结局
- Tegner Activity Score(at baseline (2 years after surgery))
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(at baseline (2 years after surgery))
- International Knee Documentation Committee (IKDC)(at baseline (2 years after surgery))
- Time to return to sports(at baseline (2 years after surgery))
- EuroQoL-5D-5L (EQ 5D 5L)(at baseline (2 years after surgery))
- ACL- RSI Score(at baseline (2 years after surgery))
- Time to return to work(at baseline (2 years after surgery))