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.
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 Type
OBSERVATIONAL
Enrollment
13
Primary surgical reconstruction of the rupture anterior cruciate ligament
University of Michigan
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Change in Articular cartilage surface roughness
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (preop), 12 months
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
Knee laxity will be measured with KT-2000 testing
Time frame: Baseline (preop), 12 months
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