Anterior Cruciate Ligament InjuriesNCT04968665
The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
An observational study of Anterior Cruciate Ligament Injuries and Cartilage Degeneration, run by Peking University Third Hospital.
Trial summary
Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Cartilage Degeneration
- What is being tested?
- gait testing, functional MRI
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Jan 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Thirty patients with ACL rupture undergoing ACL reconstruction surgery at the Institute of Sports Medicine, Peking University Third Hospital would be included in the study cohort were included, A total of 30 healthy volunteers with no history of musculoskeletal system injury or surgery in bilateral lower extremities would be included
Who may be able to join
- Unilateral ACL rupture of the knee
Who cannot join
- concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
Read the detailed description
Cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (ACLR), which may develop into knee osteoarthritis (disability rate 21.3%). Alterations in joint biomechanical properties play an important role in cartilage degeneration after ACLR. However, the mechanism remains unclear.
Our research studied the joint kinematics and kinetics properties after ACLR and found significant changes in biomechanics in the ACLR knees. Therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage.
This study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional MRI. This study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after ACLR, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after ACLR. The study aims to clarify the mechanism of cartilage degeneration after ACLR and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after ACLR.
- Being tested
- gait testing, functional MRI
- Keywords
- sports biomechanics, joint loading, anterior cruciate ligament reconstruction, cartilage degeneration, functional MRI
- 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.
gait testing, functional MRIDiagnostic test
diagnostic tests including the gait testing and functional MRI
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | gait testing and MRI at baseline for healthy volunteers Receives: Diagnostic Test: gait testing, functional MRI | |
| ACL-deficient patients | gait testing and MRI at pre-operation, 6 months post-operation, 1 year post-operation, 2 years post-operation Receives: Diagnostic Test: gait testing, functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: On the day of enrollment.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: At 6 months post operation.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: At 12 months post operation.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: At 2 years post operation.
knee T2 value
knee T1 rho value by functional MRI
Measured: On the day of enrollment.
knee T2 value
knee T1 rho value by functional MRI
Measured: At 6 months post operation.
knee T2 value
knee T1 rho value by functional MRI
Measured: At 12 months post operation.
knee T2 value
knee T1 rho value by functional MRI
Measured: At 2 years post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: On the day of enrollment.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 6 months post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 12 months post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 2 years post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: On the day of enrollment.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 6 months post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 12 months post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 2 years post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: On the day of enrollment.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 6 months post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 12 months post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 2 years post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: On the day of enrollment.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 6 months post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 12 months post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 2 years post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2024 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Shuang, Peking University Third Hospital
- Investigators
- Shuang Ren, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968665
- Sponsor's protocol ID
- M2019434
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
- ClinicalTrials.gov ID
- NCT04968665
- Acronym / sponsor ID
- M2019434
- Keywords
- sports biomechanics, joint loading, anterior cruciate ligament reconstruction, cartilage degeneration, functional MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 20 Jul 2021 (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.
Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
Detailed description
Cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (ACLR), which may develop into knee osteoarthritis (disability rate 21.3%). Alterations in joint biomechanical properties play an important role in cartilage degeneration after ACLR. However, the mechanism remains unclear.
Our research studied the joint kinematics and kinetics properties after ACLR and found significant changes in biomechanics in the ACLR knees. Therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage.
This study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional MRI. This study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after ACLR, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after ACLR. The study aims to clarify the mechanism of cartilage degeneration after ACLR and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after ACLR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Diagnostic Test: gait testing, functional MRIgait testing and MRI at baseline for healthy volunteers |
| ACL-deficient patients | – | Diagnostic Test: gait testing, functional MRIgait testing and MRI at pre-operation, 6 months post-operation, 1 year post-operation, 2 years post-operation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty patients with ACL rupture undergoing ACL reconstruction surgery at the Institute of Sports Medicine, Peking University Third Hospital would be included in the study cohort were included, A total of 30 healthy volunteers with no history of musculoskeletal system injury or surgery in bilateral lower extremities would be included
Key inclusion criteria (1 listed)
- Unilateral ACL rupture of the knee
Key exclusion criteria (1 listed)
- concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks
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 |
|---|---|---|
| gait testing, functional MRIdiagnostic tests including the gait testing and functional MRI | Diagnostic test | ACL-deficient patients, healthy volunteers |
Primary outcome
knee T1 rho value
Time frame: On the day of enrollment.
knee T1 rho value by functional MRI
knee T1 rho value
Time frame: At 6 months post operation.
knee T1 rho value by functional MRI
knee T1 rho value
Time frame: At 12 months post operation.
knee T1 rho value by functional MRI
knee T1 rho value
Time frame: At 2 years post operation.
knee T1 rho value by functional MRI
knee T2 value
Time frame: On the day of enrollment.
knee T1 rho value by functional MRI
knee T2 value
Time frame: At 6 months post operation.
knee T1 rho value by functional MRI
knee T2 value
Time frame: At 12 months post operation.
knee T1 rho value by functional MRI
knee T2 value
Time frame: At 2 years post operation.
knee T1 rho value by functional MRI
knee extension angles
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee extension angles
Time frame: At 6 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee extension angles
Time frame: At 12 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee extension angles
Time frame: At 2 years post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee moments
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee moments
Time frame: At 6 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee moments
Time frame: At 12 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee moments
Time frame: At 2 years post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, 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, running, cutting and jumping
ground reaction force
Time frame: At 6 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
ground reaction force
Time frame: At 12 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
ground reaction force
Time frame: At 2 years post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee rotation angles
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee rotation angles
Time frame: At 6 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee rotation angles
Time frame: At 12 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee rotation angles
Time frame: At 2 years post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- 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.
Shuang Ren principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Cartilage Degeneration, run by Peking University Third Hospital.
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 1 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shuang Ren (+8617610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee T1 rho value (time frame: On the day of enrollment.). The study lists 24 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 20 Jul 2021.