Ultrasound Evaluation of Hamstring Tendon Regeneration After ACL Reconstruction and Its Influence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior Cruciate Ligament injury and reconstruction group<br>According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury. | Other: no intervention<br>* This is an observation study, with no intervention<br>|
| normal control group<br>According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries. | Other: no intervention<br>* This is an observation study, with no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak ground reaction force | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| peak ground reaction force | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| peak ground reaction force | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| peak ground reaction force | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| peak ground reaction force | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| angle of hip in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| angle of hip in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| angle of hip in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| angle of hip in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| angle of hip in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| bilateral knee extension torque | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| bilateral knee extension torque | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| bilateral knee extension torque | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| bilateral knee extension torque | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| bilateral knee extension torque | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| knee flexion torque at different angles | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| knee flexion torque at different angles | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| knee flexion torque at different angles | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| knee flexion torque at different angles | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| knee flexion torque at different angles | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| angular velocities | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| angular velocities | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| angular velocities | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| angular velocities | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| angular velocities | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | On the day of enrollment. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | On the day of enrollment. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 2 weeks after Anterior Cruciate Ligament reconstruction. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 2 weeks after Anterior Cruciate Ligament reconstruction. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| the thickness of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| the cross-sectional area of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| shear wave velocity of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | On the day of enrollment. | 
| shear wave velocity of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| shear wave velocity of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| shear wave velocity of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| shear wave velocity of the semitendinosus | Ultrasound evaluation was made by Ultrasonic detector. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| torque of hip, knee and ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| torque of hip, knee and ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| torque of hip, knee and ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| torque of hip, knee and ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| torque of hip, knee and ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| angle of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| angle of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| angle of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| angle of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| angle of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| angle of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| angle of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| angle of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| angle of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| angle of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| torque of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| torque of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| torque of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| torque of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| torque of knee joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 
| torque of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | On the day of enrollment. | 
| torque of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 3 months after Anterior Cruciate Ligament reconstruction. | 
| torque of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 6 months after Anterior Cruciate Ligament reconstruction. | 
| torque of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 12 months after Anterior Cruciate Ligament reconstruction. | 
| torque of ankle joints in different stages | Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping. | At 24 months after Anterior Cruciate Ligament reconstruction. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The International Knee Documentation Committee (IKDC) score | The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100. | On the day of enrollment, at 3 months, 6 months, 12 months after operation and 24 months after Anterior Cruciate Ligament reconstruction. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament, gait analysis, plantar pressure, Ultrasound evaluation