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

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Other: no intervention

• Registration Number: NCT04961736
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-02
• Primary Completion: 2020-01-08
• Study First Submitted: 2020-06-29
• Status Verified: 2020-07
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal control group	no intervention	According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
Anterior Cruciate Ligament injury and reconstruction group	no intervention	According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.

Primary Outcome Measures

Name	Time	Method
bilateral knee extension torque	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	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	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	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	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	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	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	At 24 months after Anterior Cruciate Ligament reconstruction.	Ultrasound evaluation was made by Ultrasonic detector.
shear wave velocity of the semitendinosus	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	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	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	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	At 24 months after Anterior Cruciate Ligament reconstruction.	Ultrasound evaluation was made by Ultrasonic detector.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China