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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04961736
• Other study ID #: OR005
• Status: Active, not recruiting
• Start date: February 2, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2022
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Other:
• no intervention
This is an observation study, with no intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	angular velocities	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.	On the day of enrollment.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	On the day of enrollment.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	On the day of enrollment.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 2 weeks after Anterior Cruciate Ligament reconstruction.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 2 weeks after Anterior Cruciate Ligament reconstruction.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 3 months after Anterior Cruciate Ligament reconstruction.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 3 months after Anterior Cruciate Ligament reconstruction.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 6 months after Anterior Cruciate Ligament reconstruction.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 6 months after Anterior Cruciate Ligament reconstruction.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 12 months after Anterior Cruciate Ligament reconstruction.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 12 months after Anterior Cruciate Ligament reconstruction.
Primary	the thickness of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 24 months after Anterior Cruciate Ligament reconstruction.
Primary	the cross-sectional area of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 24 months after Anterior Cruciate Ligament reconstruction.
Primary	shear wave velocity of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	On the day of enrollment.
Primary	shear wave velocity of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 3 months after Anterior Cruciate Ligament reconstruction.
Primary	shear wave velocity of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 6 months after Anterior Cruciate Ligament reconstruction.
Primary	shear wave velocity of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 12 months after Anterior Cruciate Ligament reconstruction.
Primary	shear wave velocity of the semitendinosus	Ultrasound evaluation was made by Ultrasonic detector.	At 24 months after Anterior Cruciate Ligament reconstruction.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.