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Clinical Trials/NCT04961736
NCT04961736
Unknown
Not Applicable

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

Peking University Third Hospital1 site in 1 country110 target enrollmentFebruary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injuries
Sponsor
Peking University Third Hospital
Enrollment
110
Locations
1
Primary Endpoint
bilateral knee extension torque
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2018
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

bilateral knee extension torque

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: At 24 months after Anterior Cruciate Ligament reconstruction.

Ultrasound evaluation was made by Ultrasonic detector.

shear wave velocity of the semitendinosus

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: At 24 months after Anterior Cruciate Ligament reconstruction.

Ultrasound evaluation was made by Ultrasonic detector.

Secondary Outcomes

  • 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.)

Study Sites (1)

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