Feasibility Trial Using Imaging and Biochemical Technologies to Measure Knee Cartilage Composition in Acute ACL Injury
Feasibility Trial Using Imaging and Biochemical Technologies to Measure Knee Cartilage Composition in Acute ACL Injury
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.
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.
Inclusion Criteria:

 -  Skeletally mature subjects with age 13 - 70 years

 -  Sustain an acute full ACL rupture in one knee < 28 day

 -  May or may not undergo ACL reconstruction

 -  Low grade injury to the collateral ligaments not resulting in instability and not
 requiring reconstruction will be included

 Exclusion Criteria:

 -  Radiographic evidence of early osteoarthritis, defined as Grade 1 joint space
 narrowing or Grade 1 osteophyte formation

 -  Injuries to other ligaments requiring surgical intervention

 -  Have cartilage resurfacing procedures performed at the time of injury

 -  Inability to undergo the standard pre- and post-injury/operative rehabilitation

 -  Varus or valgus instability requiring ligament repair or reconstruction (from clinical
 exam at time of injury)

 -  History of osteoarthritis and inflammatory arthritis

 -  Women who are pregnant are excluded

 -  Previous injury and/or surgery on either knee