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临床试验/NCT04961736
NCT04961736Unknown不适用

Ultrasound Evaluation of Hamstring Tendon Regeneration After Anterior Cruciate Ligament Reconstruction and Its Influence on Gait Touch Information

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年2月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
1
主要终点
bilateral knee extension torque

研究概览

简要总结

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

详细描述

Objective

to analyze the shape and function of the regenerated hamstring tendon within 2 years after the removal of the hamstring tendon in ACL reconstruction, reveal the change rule of the characteristics of hamstring tendon regeneration and its biomechanical changes, and guide the selection of operation and postoperative rehabilitation.

Methods: 55 healthy people and 55 male patients with ACL reconstruction were recruited. All completed the basic rehabilitation training under the guidance of the postoperative rehabilitation program. Using infrared motion capture system, three-dimensional force measuring platform, isokinetic muscle force testing system and ultrasound, the anterior cruciate ligament reconstruction patients were tested before operation, 2 weeks, 3 months, 6 months, 12 months after operation and 24 months after operation.

Outcome evaluation indicators and statistical methods: evaluation indicators: (1) three dimensional motion capture and analysis results: 1) peak ground reaction force; 2) three-dimensional angle and torque of hip, knee and ankle joints in different stages; (2) isokinetic muscle strength results: bilateral knee extension torque and knee flexion torque at different angles and angular velocities. (3)Ultrasound evaluation: the thickness, cross-sectional area and shear wave velocity of the semitendinosus were measured.

Statistical methods: ① repeated measurement analysis of variance (ANOVA) was used to test the effects of different time after operation on the three-dimensional gait characteristics, muscle strength and tendon regeneration characteristics. ② Independent sample t-test was used to test the three-dimensional characteristics, muscle strength and tendon condition of patients at different time points after operation. ③ The difference of three-dimensional gait characteristics, muscle strength and tendon between the healthy side and the affected side at different time points after operation were examined by paired sample t-test. ④ Bivariate correlation analysis was used to analyze whether the thickness, cross-sectional area, shear wave propagation velocity and postoperative time were related.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-35 years old
  • Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
  • With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
  • All participants have no known disorders or diseases other than ACL rupture.

排除标准

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

结局指标

主要结局

bilateral knee extension torque

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

angle of hip in different stages

时间窗: At 12 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

angle of knee joints in different stages

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

angle of ankle joints in different stages

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

torque of ankle joints in different stages

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

torque of knee joints in different stages

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

knee flexion torque at different angles

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

the cross-sectional area of the semitendinosus

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Ultrasound evaluation was made by Ultrasonic detector.

shear wave velocity of the semitendinosus

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Ultrasound evaluation was made by Ultrasonic detector.

torque of hip, knee and ankle joints in different stages

时间窗: At 12 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

peak ground reaction force

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

angular velocities

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

the thickness of the semitendinosus

时间窗: At 24 months after Anterior Cruciate Ligament reconstruction.

Ultrasound evaluation was made by Ultrasonic detector.

次要结局

  • The International Knee Documentation Committee (IKDC) score(On the day of enrollment, at 3 months, 6 months, 12 months after operation and 24 months after Anterior Cruciate Ligament reconstruction.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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