Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
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|ClinicalTrials.gov Identifier: NCT03497780|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment|
|ACL - Anterior Cruciate Ligament Rupture ACL Injury Healthy||Procedure: Anterior cruciate ligament reconstruction|
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|
|Estimated Enrollment :||38 participants|
|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|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2021|
Patients with ACL tears
Procedure: Anterior cruciate ligament reconstruction
Primary surgical reconstruction of the rupture anterior cruciate ligament
- 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.
- 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 ]Knee laxity will be measured with KT-2000 testing
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497780
|Contact: Elizabeth Enselman, ATCfirstname.lastname@example.org|
|Contact: Jaimee Gauthier, BAemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: Elizabeth Enselman, ATC 734-615-0768 firstname.lastname@example.org|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Liz Enselman, MEd, ATC 734-615-0768 email@example.com|
|Sub-Investigator: Asheesh Bedi, MD|
|Sub-Investigator: Yingfang Ao, MD|