Clinical trial NCT04961736: Ultrasound Evaluation of Hamstring Tendon Regeneration After ACL Reconstruction and Its Influence
Official title: Ultrasound Evaluation of Hamstring Tendon Regeneration After Anterior Cruciate Ligament Reconstruction and Its Influence on Gait Touch Information
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament
gait analysis
plantar pressure
Ultrasound evaluation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria: Age: 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.

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.

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.

Primary outcomes:
measure: peak ground reaction force
timeFrame: On the day of enrollment.
measure: peak ground reaction force
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: peak ground reaction force
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: peak ground reaction force
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: peak ground reaction force
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: angle of hip in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: angle of hip in different stages
timeFrame: On the day of enrollment.
measure: angle of hip in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: angle of hip in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: angle of hip in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: bilateral knee extension torque
timeFrame: On the day of enrollment.
measure: bilateral knee extension torque
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: bilateral knee extension torque
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: bilateral knee extension torque
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: bilateral knee extension torque
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: knee flexion torque at different angles
timeFrame: On the day of enrollment.
measure: knee flexion torque at different angles
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: knee flexion torque at different angles
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: knee flexion torque at different angles
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: knee flexion torque at different angles
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: angular velocities
timeFrame: On the day of enrollment.
measure: angular velocities
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: angular velocities
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: angular velocities
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: angular velocities
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: the thickness of the semitendinosus
timeFrame: On the day of enrollment.
measure: the cross-sectional area of the semitendinosus
timeFrame: On the day of enrollment.
measure: the thickness of the semitendinosus
timeFrame: At 2 weeks after Anterior Cruciate Ligament reconstruction.
measure: the cross-sectional area of the semitendinosus
timeFrame: At 2 weeks after Anterior Cruciate Ligament reconstruction.
measure: the thickness of the semitendinosus
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: the cross-sectional area of the semitendinosus
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: the thickness of the semitendinosus
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: the cross-sectional area of the semitendinosus
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: the thickness of the semitendinosus
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: the cross-sectional area of the semitendinosus
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: the thickness of the semitendinosus
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: the cross-sectional area of the semitendinosus
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: shear wave velocity of the semitendinosus
timeFrame: On the day of enrollment.
measure: shear wave velocity of the semitendinosus
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: shear wave velocity of the semitendinosus
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: shear wave velocity of the semitendinosus
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: shear wave velocity of the semitendinosus
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: torque of hip, knee and ankle joints in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: torque of hip, knee and ankle joints in different stages
timeFrame: On the day of enrollment.
measure: torque of hip, knee and ankle joints in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: torque of hip, knee and ankle joints in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: torque of hip, knee and ankle joints in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: angle of knee joints in different stages
timeFrame: On the day of enrollment.
measure: angle of knee joints in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: angle of knee joints in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: angle of knee joints in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: angle of knee joints in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: angle of ankle joints in different stages
timeFrame: On the day of enrollment.
measure: angle of ankle joints in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: angle of ankle joints in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: angle of ankle joints in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: angle of ankle joints in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: torque of knee joints in different stages
timeFrame: On the day of enrollment.
measure: torque of knee joints in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: torque of knee joints in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: torque of knee joints in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: torque of knee joints in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
measure: torque of ankle joints in different stages
timeFrame: On the day of enrollment.
measure: torque of ankle joints in different stages
timeFrame: At 3 months after Anterior Cruciate Ligament reconstruction.
measure: torque of ankle joints in different stages
timeFrame: At 6 months after Anterior Cruciate Ligament reconstruction.
measure: torque of ankle joints in different stages
timeFrame: At 12 months after Anterior Cruciate Ligament reconstruction.
measure: torque of ankle joints in different stages
timeFrame: At 24 months after Anterior Cruciate Ligament reconstruction.
Secondary outcomes:
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: On the day of enrollment, at 3 months, 6 months, 12 months after operation and 24 months after Anterior Cruciate Ligament reconstruction.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hongshi Huang, Doctor
role: STUDY_CHAIR
References: