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

NCT02010125 | Completed

• 1 other identifier: AFstudy
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Injury of Anterior Cruciate Ligament

Keywords

Anterior Cruciate Ligament (ACL); Magnetic Resonance Imaging (MRI); Osteoarthritis (OA); Bio-specimens; Acute ACL Injury; Arthritis Foundation (AF)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Collect and store bio-specimens

  Baseline - 12 months

• Functional Assessments

  6 months, 12 months

• Patient-Reported Questionnaires

  Baseline - 12 months

Study Arms (1)

Acute ACL injury

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

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and Women with acute ACL injury (within 28 days)

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Arthritis Foundation: collaborator

Study Sites (1)

UCSF Orthopaedic Institute

San Francisco, California, 94158, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, Whole Blood, Synovial Fluid

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chunbong B Ma, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)