ACL - Anterior Cruciate Ligament RuptureNCT03497780
Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
An observational study of ACL - Anterior Cruciate Ligament Rupture and ACL Injury, run by University of Michigan at 2 sites in United States.
Trial summary
The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture, ACL Injury, Healthy
- What is being tested?
- Anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2018to 25 Mar 2021
- 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: Community sample
Who may be able to join
- 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 Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament
Who cannot join
- Body Mass Index < 18.5 or >35 - 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
- Pregnant women as they are not eligible for surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Synovial Inflammation, Functional Imaging, Clinical Outcomes, and Cartilage Biomarkers
The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (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 post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.
Read the detailed description
Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis.
Patient Selection and Enrollment: 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. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.
- Being tested
- Anterior cruciate ligament reconstruction
- Keywords
- Healthy Volunteers, ACL (Anterior Cruciate Ligament) tear
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cruciate ligament reconstructionProcedure or surgery
Primary surgical reconstruction of the rupture anterior cruciate ligament
| Study group | Role | What they receive |
|---|---|---|
| ACL Tear | Patients with ACL tears Receives: Procedure: Anterior cruciate ligament reconstruction | |
| Healthy Subjects | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Articular cartilage surface roughness
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Measured: Baseline (preop), 12 months
Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration
One-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.
Measured: Baseline (preop), 12 months
Change in International Knee Documentation Committee (IKDC) score
One year change in IKDC, a patient-reported outcome measure specific to knee injuries.
Measured: Baseline (preop), 12 months
Secondary outcomes (4)
Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.
Measured: Baseline (preop), 12 months
Change in concentration of biomarkers of inflammation and cartilage metabolism.
Measured: Baseline (preop), 12 months
Change in patient-reported outcome measures
Measured: Baseline (preop), 12 months
Change in knee laxity
Knee laxity will be measured with KT-2000 testing
Measured: Baseline (preop), 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start8 Nov 2018
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Why it stopped: Due to staff departure, study is being discontinued per allocation of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center
- Responsible party
- Principal investigator, Tristan Maerz, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497780
- Sponsor's protocol ID
- HUM00137279
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2018
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. 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 Synovial Inflammation, Functional Imaging, Clinical Outcomes, and Cartilage Biomarkers
- ClinicalTrials.gov ID
- NCT03497780
- Acronym / sponsor ID
- HUM00137279
- Keywords
- Healthy Volunteers, ACL (Anterior Cruciate Ligament) tear
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to staff departure, study is being discontinued per allocation of resources.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Peking University Health Science Center
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 13 Apr 2018 (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 mesenchymal stem cell (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 post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.
Detailed description
Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis.
Patient Selection and Enrollment: 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. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL Tear | – | Procedure: Anterior cruciate ligament reconstructionPatients with ACL tears |
| Healthy Subjects | – | –Healthy subjects |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- 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 Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament
Key exclusion criteria (4 listed)
- Body Mass Index < 18.5 or >35 - 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
- Pregnant women as they are not eligible for surgery
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 |
|---|---|---|
| Anterior cruciate ligament reconstructionPrimary surgical reconstruction of the rupture anterior cruciate ligament | Procedure or surgery | ACL Tear |
Primary outcome
Change in Articular cartilage surface roughness
Time frame: Baseline (preop), 12 months
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration
Time frame: Baseline (preop), 12 months
One-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.
Change in International Knee Documentation Committee (IKDC) score
Time frame: Baseline (preop), 12 months
One year change in IKDC, a patient-reported outcome measure specific to knee injuries.
4 secondary outcomes
Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.
Time frame: Baseline (preop), 12 months
Change in concentration of biomarkers of inflammation and cartilage metabolism.
Time frame: Baseline (preop), 12 months
Change in patient-reported outcome measures
Time frame: Baseline (preop), 12 months
Change in knee laxity
Time frame: Baseline (preop), 12 months
Results and safety
The study was stopped early (reason given: Due to staff departure, study is being discontinued per allocation of resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL - Anterior Cruciate Ligament Rupture and ACL Injury, run by University of Michigan at 2 sites in United States.
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 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: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Due to staff departure, study is being discontinued per allocation of resources.). 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?
Change in Articular cartilage surface roughness (time frame: Baseline (preop), 12 months). The study lists 3 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 5 Apr 2023.