Anterior Cruciate Ligament InjuriesNCT04970706
Cartilage Injury and Remodeling After ACL Rupture and Reconstruction: Functional Imaging and Biomarkers
An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial summary
The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions.
Who may be able to join
- - Males and females, aged 18 - 30 years
- Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
- Surgical reconstruction performed using a single-bundle technique utilizing an autograft
- No history of ipsilateral traumatic knee injury or fracture
- No evidence of PCL injury or more than grade 1 injury to the MCL or LCL
Who cannot join
- - BMI < 18.5 or >35 kg/m2
- Injury occurred longer than 4 weeks before enrollment
- Intra-articular steroid injection within 3 months of injury
- Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality, 100191
yanfang jiang, MSc., 15011420759, anthea_jiang@126.com
About this study
Official title: Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Functional Imaging and Biomarkers
The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of PTOA after ACL injury and reconstruction.
Read the detailed description
In efforts to study the pathoetiology of post-traumatic osteoarthritis (PTOA), we propose a collaborative, prospective cohort study of 38 patients undergoing primary anterior cruciate ligament (ACL) reconstruction after ACL rupture. We will assess the longitudinal progression of patient-reported outcomes, knee laxity, MRI-based articular cartilage morphology and composition, and serum-borne biomarkers of cartilage degeneration up to 1 year of follow-up. Furthermore, stem cell mobilization, chemokine and pro-inflammatory cytokine concentrations, and inflammatory cell recruitment into synovial tissue will be measured from intraoperatively-collected samples. We will perform mixed multivariate linear regression modeling to elucidate potentially novel relationships between patient demographics, anatomy, biological factors, and downstream alterations in articular cartilage morphology and composition. We request $200,000 in funding over a two-year duration.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- ACL reconstruction
- 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.
ACL reconstructionProcedure or surgery
All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Volunteers were healthy people without ACL rupture | |
| Patients with ACL Rupture | All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft. Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectives measure of knee stability
Knee stability (anterior-posterior laxity) will be measured utilizing the KT-2000 arthrometer, based on the side-to-side difference (SSD) observed between the injured and the healthy, contralateral knee. Subjects will be tested at 90 days, 180 days, and 1 year after surgery, with maximum manual force performed at 30 and 90 degrees of knee flexion.
Measured: 3 months, 6 months, 12 months
COMP
Cartilage Biomarker Analysis;
Measured: 12 months after operation
Interleukin-1
Chemokines and Pro-Inflammatory Cytokines in Synovial Fluid;
Measured: 12 months after operation
MMP-1
Soft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid
Measured: 12 months after operation
colony-forming units (CFU)
The CFU assay is a common means of analyzing MSC concentration in bodily fluids
Measured: 12 months after operation
Cartilage morphology
Quantitative MRI of cartilage morphology
Measured: 12 months after operation
Magnetic resonance imaging
Quantitative MRI of Cartilage Composition
Measured: 12 months after operation
Secondary outcomes (3)
Tegner Activity Scale
knee evaluation are commonly used to document a patient's activity level
Measured: 12 months after operation
Lysholm Knee Scale
knee evaluation are commonly used to document a patient's functional outcomes
Measured: 12 months after operation
International Knee Documentation Committee (IKDC) subjective Scale
knee evaluation are commonly used to document a patient's functional outcomes
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970706
- Sponsor's protocol ID
- M2017401
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Functional Imaging and Biomarkers
- ClinicalTrials.gov ID
- NCT04970706
- Acronym / sponsor ID
- M2017401
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 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.
The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of PTOA after ACL injury and reconstruction.
Detailed description
In efforts to study the pathoetiology of post-traumatic osteoarthritis (PTOA), we propose a collaborative, prospective cohort study of 38 patients undergoing primary anterior cruciate ligament (ACL) reconstruction after ACL rupture. We will assess the longitudinal progression of patient-reported outcomes, knee laxity, MRI-based articular cartilage morphology and composition, and serum-borne biomarkers of cartilage degeneration up to 1 year of follow-up. Furthermore, stem cell mobilization, chemokine and pro-inflammatory cytokine concentrations, and inflammatory cell recruitment into synovial tissue will be measured from intraoperatively-collected samples. We will perform mixed multivariate linear regression modeling to elucidate potentially novel relationships between patient demographics, anatomy, biological factors, and downstream alterations in articular cartilage morphology and composition. We request $200,000 in funding over a two-year duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Volunteers were healthy people without ACL rupture |
| Patients with ACL Rupture | – | Procedure: ACL reconstructionAll patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions.
Key inclusion criteria (5 listed)
- - Males and females, aged 18 - 30 years
- Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
- Surgical reconstruction performed using a single-bundle technique utilizing an autograft
- No history of ipsilateral traumatic knee injury or fracture
- No evidence of PCL injury or more than grade 1 injury to the MCL or LCL
Key exclusion criteria (4 listed)
- - BMI < 18.5 or >35 kg/m2
- Injury occurred longer than 4 weeks before enrollment
- Intra-articular steroid injection within 3 months of injury
- Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
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 |
|---|---|---|
| ACL reconstructionAll patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft. | Procedure or surgery | Patients with ACL Rupture |
Primary outcome
Objectives measure of knee stability
Time frame: 3 months, 6 months, 12 months
Knee stability (anterior-posterior laxity) will be measured utilizing the KT-2000 arthrometer, based on the side-to-side difference (SSD) observed between the injured and the healthy, contralateral knee. Subjects will be tested at 90 days, 180 days, and 1 year after surgery, with maximum manual force performed at 30 and 90 degrees of knee flexion.
COMP
Time frame: 12 months after operation
Cartilage Biomarker Analysis;
Interleukin-1
Time frame: 12 months after operation
Chemokines and Pro-Inflammatory Cytokines in Synovial Fluid;
MMP-1
Time frame: 12 months after operation
Soft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid
colony-forming units (CFU)
Time frame: 12 months after operation
The CFU assay is a common means of analyzing MSC concentration in bodily fluids
Cartilage morphology
Time frame: 12 months after operation
Quantitative MRI of cartilage morphology
Magnetic resonance imaging
Time frame: 12 months after operation
Quantitative MRI of Cartilage Composition
3 secondary outcomes
Tegner Activity Scale
Time frame: 12 months after operation
Lysholm Knee Scale
Time frame: 12 months after operation
International Knee Documentation Committee (IKDC) subjective Scale
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
yingfang ao, M.D. study director
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 5 inclusion and 4 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 21 Jul 2021. 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?
Contact yanfang jiang, Msc. (15011420759, anthea_jiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectives measure of knee stability (time frame: 3 months, 6 months, 12 months). The study lists 7 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 21 Jul 2021.