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

Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior Cruciate Ligament injury and reconstruction group; According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.	Other: no intervention; This is an observation study, with no intervention.
normal control group; According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.	Other: no intervention; This is an observation study, with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
the moment of knee extension in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
the moment of knee flexion in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 24th weeks after Anterior Cruciate Ligament reconstruction.
walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 48th weeks after Anterior Cruciate Ligament reconstruction.
ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 24th weeks after Anterior Cruciate Ligament reconstruction.
ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 48th weeks after Anterior Cruciate Ligament reconstruction.
knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 24th weeks after Anterior Cruciate Ligament reconstruction.
knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 48th weeks after Anterior Cruciate Ligament reconstruction.
the moment of knee extension in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 24th weeks after Anterior Cruciate Ligament reconstruction.
the moment of knee extension in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 48th weeks after Anterior Cruciate Ligament reconstruction.
the moment of knee flexion in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 24th weeks after Anterior Cruciate Ligament reconstruction.
the moment of knee flexion in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	at 48th weeks after Anterior Cruciate Ligament reconstruction.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): January 8, 2020
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: gait analysis; plantar pressure; anterior cruciate ligament; multi-body dynamics modeling
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: OR003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No