The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction

July 6, 2020 updated by: Peking University Third Hospital
Investigating the biomechanics for the PCL ruptured or reconstructed patients during walking, jogging, cutting, jumping. To 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 Overview

Status

Completed

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

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion:age of 18-45 years old. Healthy volunteers: no history of neuro or musculoskeletal system injury that may affect the movements. Isolated PCL rupture patients: The inclusion criteria included an isolated PCL rupture of at least 3 months' duration. The exclusion criteria were (1) additional knee ligament or meniscal damage; (2) severe damage to the ipsilateral hip, ankle joint, or contralateral lower limb (ligament ruptures or bone fractures); (3) age >50 years (to avoid age-induced osteoarthritis interference); (4) any cartilage injury grade >2 according to the Outerbridge classification; and (5) Tegner score18 <3.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
This is an observation study, with no intervention
Posterior cruciate ligament injury group
According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury.
This is an observation study, with no intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The International Knee Documentation Committee (IKDC) score
Time Frame: On the day of enrollment.
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.
On the day of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2014

Primary Completion (ACTUAL)

November 27, 2018

Study Completion (ACTUAL)

November 30, 2018

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (ACTUAL)

July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

June 1, 2020

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)?

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

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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