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Due to staff departure, study is being discontinued per allocation of resources.
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| Name | Class |
|---|---|
| Peking University Health Science Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL Tear | Patients with ACL tears |
| |
| Healthy Subjects | Healthy subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cruciate ligament reconstruction | Procedure | Primary surgical reconstruction of the rupture anterior cruciate ligament |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States | ||
| University of Michigan |
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Serum and plasma
| Change in patient-reported outcome measures | Baseline (preop), 12 months |
| Change in knee laxity | Knee laxity will be measured with KT-2000 testing | Baseline (preop), 12 months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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