Clinical trial NCT04462432: Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction
Official title: Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament
gait analysis
plantar pressure
multi-body dynamics modeling
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 150
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: 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.

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: walking speed
timeFrame: On the day of enrollment.
measure: walking speed
timeFrame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
measure: walking speed
timeFrame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
measure: ground reaction force
timeFrame: On the day of enrollment.
measure: ground reaction force
timeFrame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
measure: ground reaction force
timeFrame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
measure: knee flexion angle
timeFrame: On the day of enrollment.
measure: knee flexion angle
timeFrame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
measure: knee flexion angle
timeFrame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
measure: the moment of knee extension in the gait cycle
timeFrame: On the day of enrollment.
measure: the moment of knee extension in the gait cycle
timeFrame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
measure: the moment of knee extension in the gait cycle
timeFrame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
measure: the moment of knee flexion in the gait cycle
timeFrame: On the day of enrollment.
measure: the moment of knee flexion in the gait cycle
timeFrame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
measure: the moment of knee flexion in the gait cycle
timeFrame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
Secondary outcomes:
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: On the day of enrollment, at 24th and 48th weeks 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: