- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464343
The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The posterior cruciate ligament (PCL) is an essential structure in knee stabilization. Knee cartilage degeneration after a PCL injury has been reported in several studies. Understanding the changes in movement patterns of patients with PCL ruptures could help clinicians make specific treatment protocols to restore patients' sporting ability and prevent joint degeneration. However, the kinematics and kinetics of the lower limb in patients with PCL injuries are still not clear.
Methods: Three-dimensional gait analysis system, force plate, electromyography will be used for 55 healthy male participants (control group) and 55 male patients with isolated PCL-deficiency (PCL-d group) during walking, jogging, cutting, jumping. Repeated measurement two-factor analysis of variance will be performed to determine differences between involved and uninvolved legs in the PCL-d group and control group at different rehabilitation times (prior reconstruction surgery, 6 months, and 1-year post PCL reconstruction surgery). Three-dimensional gait analysis and computer-aided analysis technology of plantar pressure information were used to study the changes of PCL after fracture and reconstruction. Based on the plantar pressure information, the movement parameters, and individual attribute parameters, establish a knee joint biomechanical evaluation model to quantify and evaluate the plantar pressure information under dynamic load-bearing state after PCL fracture. Provide a precise basis for the biomechanical state of the knee, and establish a clinically practical automatic analysis of plantar pressure information and an expert diagnostic system.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age of 18-45 years old
- Isolated PCL rupture patients: The inclusion criteria included an isolated PCL rupture of at least 3 months' duration.
- Healthy volunteers: no history of neuro or musculoskeletal system injury that may affect the movements.
Exclusion Criteria:
- additional knee ligament or meniscal damage
- severe damage to the ipsilateral hip, ankle joint, or contralateral lower limb (ligament ruptures or bone fractures)
- age >50 years (to avoid age-induced osteoarthritis interference)
- any cartilage injury grade >2 according to the Outerbridge classification
- Tegner score18 <3
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
normal control group
According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
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This is an observation study, with no intervention
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Posterior cruciate ligament injury group
According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury.
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This is an observation study, with no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
walking speed
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
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On the day of enrollment.
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ground reaction force
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
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On the day of enrollment.
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knee flexion angle
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
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On the day of enrollment.
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the moment of knee extension in the gait cycle
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
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On the day of enrollment.
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the moment of knee flexion in the gait cycle
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
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On the day of enrollment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The International Knee Documentation Committee (IKDC) score
Time Frame: On the day of enrollment.
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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.
The higher is better.
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On the day of enrollment.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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