NCT04464343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4.5 years

First QC Date

June 29, 2020

Last Update Submit

July 6, 2020

Conditions

Keywords

posterior cruciate ligamentkneehipanklebiomechanicswalkingjoggingcuttingjumping

Outcome Measures

Primary Outcomes (5)

  • walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • knee flexion angle

    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

    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

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

Secondary Outcomes (1)

  • The International Knee Documentation Committee (IKDC) score

    On the day of enrollment.

Study Arms (2)

Posterior cruciate ligament injury group

According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury.

Other: no intervention

normal control group

According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.

Other: no intervention

Interventions

This is an observation study, with no intervention

Posterior cruciate ligament injury groupnormal control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • age of 18-45 years old
  • Healthy volunteers: no history of neuro or musculoskeletal system injury that may affect the movements.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Study Officials

  • Hongshi Huang, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 9, 2020

Study Start

June 14, 2014

Primary Completion

November 27, 2018

Study Completion

November 30, 2018

Last Updated

July 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations