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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
normal control group
According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
Other: no intervention
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.
Other: no intervention
This is an observation study, with no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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