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

Posterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464343
• Other study ID #: OR006
• Status: Completed
• Start date: June 14, 2014
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 30, 2018
• Est. primary completion date: November 27, 2018
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Posterior Cruciate Ligament Tear
• Rupture

Intervention

Other:
• no intervention
This is an observation study, with no intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	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.	On the day of enrollment.
Primary	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.	On the day of enrollment.
Secondary	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. The higher is better.	On the day of enrollment.