Feasibility Trial Using Imaging and Biochemical Technologies to Measure Knee Cartilage Composition in Acute ACL Injury
Condition: Acute Injury of Anterior Cruciate Ligament
MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      This prospective longitudinal study will evaluate the biomechanical and biochemical
      abnormalities in acute ACL-injured and reconstructed knees through advanced quantitative MR
      imaging, bio-specimen collection, and functional testing.

      Researchers will recruit and retain patients with acute ACL tears within 28 days of injury,
      and follow them longitudinally at 6 weeks, 6 months, and 12 months. Standard of Care MR
      imaging will be captured at baseline, then a quantitative morphological MRI and quantitative
      T1ρ and T2 imaging of the injured and contra-lateral knees will be taken within 7 days of
      baseline, and again at 6 months, and 1 year post-injury or post-surgery. Scans will not take
      place immediately after surgery because we are not attempting to study the immediate effect
      of ACL reconstruction. The physical performance testing will not be acquired until 6 months
      follow-up because patients will have unstable knees.

      For the 6 healthy volunteers, only an MRI of the right knee will be required at 4 time points
      - baseline, 6 months, 12 months, and 18 months. The control volunteers will be used as a
      measure of reproducibility. The control volunteers will not perform any physical performance
      testing or study questionnaires. The purpose of the six control subjects is to track the
      reproducibility and physiologic variation in T1p and T2 values in a normal knee. These
      subjects will complete imaging at four time points, spaced six months apart. The results will
      help evaluate the expected range of differences in knees without a traumatic injury. This
      information will assist in the interpretation of values from the patients with ACL injuries
      as to if any observed variation is outside the expected magnitude for a healthy individual.
      The control subjects will also help monitor for any changes in the scanner reliability at our
      site and compared to the other two clinical sites. Phantoms will be scanned each month to aid
      in this process, and control subjects will add and help ensure that data collection is
      constant over time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and Women with acute ACL injury (within 28 days)
      
Biospecimen description: 
      Urine, Whole Blood, Synovial Fluid
    
Keywords: Anterior Cruciate Ligament (ACL); Magnetic Resonance Imaging (MRI); Osteoarthritis (OA); Bio-specimens; Acute ACL Injury; Arthritis Foundation (AF)