Study Stopped
Due to staff departure, study is being discontinued per allocation of resources.
Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
1 other identifier
observational
13
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
November 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2021
CompletedApril 5, 2023
March 1, 2023
2.4 years
March 23, 2018
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Articular cartilage surface roughness
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
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.
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.
Baseline (preop), 12 months
Secondary Outcomes (4)
Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.
Baseline (preop), 12 months
Change in concentration of biomarkers of inflammation and cartilage metabolism.
Baseline (preop), 12 months
Change in patient-reported outcome measures
Baseline (preop), 12 months
Change in knee laxity
Baseline (preop), 12 months
Study Arms (2)
ACL Tear
Patients with ACL tears
Healthy Subjects
Healthy subjects
Interventions
Primary surgical reconstruction of the rupture anterior cruciate ligament
Eligibility Criteria
Community sample
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Peking University Health Science Centercollaborator
Study Sites (2)
University of Michigan
Ann Arbor, Michigan, 48105, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Biospecimen
Serum and plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Investigator
Study Record Dates
First Submitted
March 23, 2018
First Posted
April 13, 2018
Study Start
November 8, 2018
Primary Completion
March 25, 2021
Study Completion
March 25, 2021
Last Updated
April 5, 2023
Record last verified: 2023-03