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

Completed

Conditions studied: Acute Injury of Anterior Cruciate Ligament

In brief

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.

Key facts

Study ID

NCT02010125

Run by

University of California, San Francisco

People needed

89

Starts

2013-11-01

Expected to finish

2017-12-01

Last updated by the study team

2018-11-13

Who can join

Age: 13 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Orthopaedic Institute — San Francisco, California, United States

Full record on ClinicalTrials.gov

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