Clinical trial NCT04464343: The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction
Official title: The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Cruciate Ligament Tear
Keywords: posterior cruciate ligament
knee
hip
ankle
biomechanics
walking
jogging
cutting
jumping
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: walking speed
timeFrame: On the day of enrollment.
measure: ground reaction force
timeFrame: On the day of enrollment.
measure: knee flexion angle
timeFrame: On the day of enrollment.
measure: the moment of knee extension in the gait cycle
timeFrame: On the day of enrollment.
measure: the moment of knee flexion in the gait cycle
timeFrame: On the day of enrollment.
Secondary outcomes:
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: On the day of enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hongshi Huang, Doctor
role: STUDY_CHAIR
References: