Anterior Cruciate Ligament InjuriesNCT04462432
Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction
An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial summary
High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2017to 31 Dec 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures). All participants have no known disorders or diseases other than ACL rupture. Exclusion criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Who may be able to join
- 18-35 years old
- Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
- With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
- All participants have no known disorders or diseases other than ACL rupture.
Who cannot join
- Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction
High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.
To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.
Read the detailed description
Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.
Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.
Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- no intervention
- Keywords
- anterior cruciate ligament, gait analysis, plantar pressure, multi-body dynamics modeling
- Medical subject headings
- Anterior Cruciate Ligament Injuries
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 |
|---|---|---|
| Anterior Cruciate Ligament injury and reconstruction group | According to the previous clinical diagnosis, volunteers who has never suffered the Anterior 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.
walking speed
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 24th weeks after Anterior Cruciate Ligament reconstruction.
walking speed
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 24th weeks after Anterior Cruciate Ligament reconstruction.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
knee flexion angle
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 24th weeks after Anterior Cruciate Ligament reconstruction.
knee flexion angle
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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 extension in the gait cycle
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
Measured: at 24th weeks after Anterior Cruciate Ligament reconstruction.
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: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
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: at 24th weeks after Anterior Cruciate Ligament reconstruction.
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: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
Measured: On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start2 Mar 2017
- Primary completion8 Jan 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 150 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
- NCT04462432
- Sponsor's protocol ID
- OR003
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 8 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction
- ClinicalTrials.gov ID
- NCT04462432
- Acronym / sponsor ID
- OR003
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament, gait analysis, plantar pressure, multi-body dynamics modeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 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.
High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.
To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.
Detailed description
Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.
Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.
Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Cruciate Ligament injury and reconstruction group | – | Other: no interventionAccording to the previous clinical diagnosis, volunteers who has never suffered the Anterior 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 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures). All participants have no known disorders or diseases other than ACL rupture. Exclusion criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Key inclusion criteria (4 listed)
- 18-35 years old
- Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
- With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
- All participants have no known disorders or diseases other than ACL rupture.
Key exclusion criteria (1 listed)
- Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
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 | Anterior Cruciate Ligament injury and reconstruction 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.
walking speed
Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
walking speed
Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
ground reaction force
Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
ground reaction force
Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
knee flexion angle
Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
knee flexion angle
Time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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 extension in the gait cycle
Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
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: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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.
the moment of knee flexion in the gait cycle
Time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
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: at 48th weeks after Anterior Cruciate Ligament reconstruction.
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, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 Anterior Cruciate Ligament Injuries, 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
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 15 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 8 Jul 2020.