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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04961736
Enrollment
110
Registered
2021-07-14
Start date
2018-02-02
Completion date
2022-12-31
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligament, gait analysis, plantar pressure, Ultrasound evaluation

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.

Interventions

OTHERno intervention

This is an observation study, with no intervention

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
torque of knee joints in different stagesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
peak ground reaction forceOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
angle of hip in different stagesAt 24 months after Anterior Cruciate Ligament reconstruction.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
bilateral knee extension torqueOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
knee flexion torque at different anglesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
angular velocitiesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
the thickness of the semitendinosusOn the day of enrollment.Ultrasound evaluation was made by Ultrasonic detector.
the cross-sectional area of the semitendinosusOn the day of enrollment.Ultrasound evaluation was made by Ultrasonic detector.
shear wave velocity of the semitendinosusOn the day of enrollment.Ultrasound evaluation was made by Ultrasonic detector.
torque of hip, knee and ankle joints in different stagesAt 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 knee joints in different stagesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
torque of ankle joints in different stagesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.
angle of ankle joints in different stagesOn the day of enrollment.Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

Secondary

MeasureTime frameDescription
The International Knee Documentation Committee (IKDC) scoreOn 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026