Posterior Cruciate Ligament TearNCT04464343
The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction
An observational study of Posterior Cruciate Ligament Tear, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Posterior Cruciate Ligament Tear
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2014to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Posterior Cruciate Ligament Tear
- Being tested
- no intervention
- Keywords
- posterior cruciate ligament, knee, hip, ankle, biomechanics, walking, jogging, cutting, jumping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observation study, with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Posterior cruciate ligament injury group | According to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury. Receives: Other: no intervention | |
| normal control group | According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: On the day of enrollment.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: On the day of enrollment.
knee flexion angle
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: 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.
Measured: 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.
Measured: On the day of enrollment.
Secondary outcomes (1)
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.
Measured: On the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start14 Jun 2014
- Primary completion27 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongshi Huang, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464343
- Sponsor's protocol ID
- OR006
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biomechanical Mechanism for Gait and Plantar Pressure Changes After Posterior Cruciate Ligament Rupture and Reconstruction
- ClinicalTrials.gov ID
- NCT04464343
- Acronym / sponsor ID
- OR006
- Conditions
- Posterior Cruciate Ligament Tear
- Keywords
- posterior cruciate ligament, knee, hip, ankle, biomechanics, walking, jogging, cutting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 14 Jun 2014 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior cruciate ligament injury group | – | Other: no interventionAccording to the previous clinical diagnosis, volunteers who has never suffered the Posterior cruciate ligament injury. |
| normal control group | – | Other: no interventionAccording to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is an observation study, with no intervention | Other | Posterior cruciate ligament injury group, normal control group |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
The International Knee Documentation Committee (IKDC) score
Time frame: On the day of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongshi Huang, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Cruciate Ligament Tear, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (time frame: On the day of enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.