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Status unknownNCT04462432Updated Jul 8, 2020

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

An observational study in Anterior Cruciate Ligament Injuries, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anterior Cruciate Ligament Injuries

Keywords

  • anterior cruciate ligament
  • gait analysis
  • plantar pressure
  • multi-body dynamics modeling
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 203 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • normal control group

    According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.

    Other: no intervention

Interventions

  • Otherno intervention

    This is an observation study, with no intervention.

06

What researchers measure

Primary outcomes

  1. walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: On the day of enrollment.

  2. walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.

  3. walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.

  4. ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: On the day of enrollment.

  5. ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.

  6. ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.

  7. knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: On the day of enrollment.

  8. knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.

  9. knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.

  10. 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.

    Time frame: On the day of enrollment.

  11. 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.

    Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.

  12. 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.

    Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.

  13. 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.

    Time frame: On the day of enrollment.

  14. 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.

    Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.

  15. 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.

    Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Secondary outcomes

  1. 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.

    Time frame: On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, 100191, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04462432
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jul 8, 2020
Start date
Mar 2, 2017
Primary completion
Jan 8, 2020
Completion
Dec 31, 2022 (estimated)
Last update
Jul 8, 2020

Study contacts

Hongshi Huang, Doctor
study chair · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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