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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04462432
• Other study ID #: OR003
• Status: Active, not recruiting
• Start date: March 2, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: June 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:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• 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
• Rupture

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	walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	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.
Primary	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.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	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.
Primary	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.
Primary	knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.