A Multi-Center Feasibility Trial Establishing Imaging and Biochemical Technologies as Measures of Knee Cartilage Composition Following Acute ACL Injury
Sponsor study identifier
observational
89
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2017
Actual (reported)This study will evaluate the bio-mechanical and biochemical abnormalities in acute ACL-injured knees over time. Data will be collected through advanced quantitative MR imaging, functional testing, and bio-specimen collection. Researchers will collect this data from the time of baseline visit, which is within 28 days of injury, through the temporal sequence of post-operative or post-injury recovery and return to activity. The hypotheses for this study are (1) that T1ρ and T2 will be significantly elevated in the lateral side of ACL-injured knees immediately after injury (indicating damage caused by initial injury), and will not fully recover at 6-month, 1-year follow ups; (2) that T1ρ and T2 will be significantly elevated in the medial side of ACL-injured knees at 1-year follow-up; and (3) that differences in the bio-marker expression patterns can be correlated with the initial MRI findings, which would provide information regarding the full spectrum of intra-articular pathology and the subsequent clinical outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 9, 2013
Actual (reported)December 12, 2013
Actual (reported)December 2016
Actual (reported)December 2017
Actual (reported)Follow patients with acute ACL tears longitudinally using advanced, quantitative morphological MR imaging.
Patients who are within 28 days of injury will be recruited in order to capture the acute phase of injury. Quantitative morphological MRI and quantitative T1p and T2 imaging of the injured and contra-lateral knees will be captured at their baseline visit (within 7 days of initial visit), and then again at 6 months and 12 months. The aim is to investigate longitudinal changes in cartilage matrix in ACL-injured and reconstructed knees using T1ρ and T2. We hypothesize that T1ρ and T2 will be significantly higher in defined sub-compartments of injured knees compared to the contralateral un-injured knees at baseline and follow-ups. Meniscus, ligamentous and cartilage abnormalities will be graded using MRI for correlation with cartilage T1ρ and T2.
Baseline - 12 months
Collect and store bio-specimens
Baseline - 12 months
Functional Assessments
6 months, 12 months
Patient-Reported Questionnaires
Baseline - 12 months
Subjects with acute ACL injury will be recruited and enrolled within 28 days of injury Serum, urine, and synovial fluid will be collected at baseline, 6wks post-injury or post-surgery, 6 months, and 1 year Patients will have a quantitative MRI on both knees 7 days after initial visit, then at 6 months and 1 year. Patients may or may not opt for ACL reconstruction Patients will have functional testing (One-legged hop tests and Star excursion balance test) at 6 months and 1 year Patients will fill out questionnaires (Knee Osteoarthritis Outcome Survey, Veteran Rand-12, Lysholm, International Knee Documentation Committee, Marx Questionnaire) at baseline, 6 weeks, 6 months, and 1 year
Men and Women with acute ACL injury (within 28 days)
UCSF Orthopaedic Institute
San Francisco, California, 94158, United States
Urine, Whole Blood, Synovial Fluid
Chunbong B Ma, MD
University of California, San Francisco
89 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
November 13, 2018
Record last verified: 2018-11
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