Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction

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

• Registration Number: NCT04462432
• 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

Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.

Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.

Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.

Study Timeline

• Study Start: 2017-03-02
• Primary Completion: 2020-01-08
• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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
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.
normal control group	no intervention	According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.

Primary Outcome Measures

Name	Time	Method
walking speed	at 48th weeks after Anterior Cruciate Ligament reconstruction.	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
ground reaction force	at 48th weeks after Anterior Cruciate Ligament reconstruction.	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
knee flexion angle	at 48th weeks after Anterior Cruciate Ligament reconstruction.	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle	at 48th weeks after Anterior Cruciate Ligament reconstruction.	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
the moment of knee flexion in the gait cycle	at 48th weeks after Anterior Cruciate Ligament reconstruction.	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

Secondary Outcome Measures

Name	Time	Method
The International Knee Documentation Committee (IKDC) score	On the day of enrollment, at 24th and 48th weeks 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