Acute Injury of Anterior Cruciate LigamentNCT02010125
Feasibility Trial Using Imaging and Biochemical Technologies to Measure Knee Cartilage Composition in Acute ACL Injury
An observational study of Acute Injury of Anterior Cruciate Ligament, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Injury of Anterior Cruciate Ligament
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Men and Women with acute ACL injury (within 28 days)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopaedic Institute
San Francisco, California, 94158
About this study
Official title: A Multi-Center Feasibility Trial Establishing Imaging and Biochemical Technologies as Measures of Knee Cartilage Composition Following 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.
Read the 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.
- Keywords
- Anterior Cruciate Ligament (ACL), Magnetic Resonance Imaging (MRI), Osteoarthritis (OA), Bio-specimens, Acute ACL Injury, Arthritis Foundation (AF)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 12 months
Secondary outcomes (3)
Collect and store bio-specimens
Blood, urine, and synovial fluid will be collected from patients at each time point (initial visit; surgery (if applicable); 6 weeks post-injury (or post-surgery, if applicable), 6 months, and 12 months). The aim is to collect, freeze, and store these samples from each time point to develop a repository of bio-specimens, which can be correlated with imaging, clinical and functional outcomes at a later phase when funding becomes available for such assays. The hypothesis is that differences in the bio-marker expression patterns can be correlated with the initial MRI findings, which provide information regarding the full spectrum of intra-articular pathology, and the subsequent clinical outcomes.
Measured: Baseline - 12 months
Functional Assessments
Physical performance and functional testing will only be preformed at 6 months and 1-year, and not during the initial visits due to functional limitations. Subjects will perform the "One-Legged Hop Tests" and the "Star Excursion Balance Test (SEBT)". The aim of the functional testing is to demonstrate the feasibility of relating the MRI derived morphological and biochemical measures to clinical and functional assessments.
Measured: 6 months, 12 months
Patient-Reported Questionnaires
In addition to demographic data, the activity level of all subjects will be evaluated using the Lysholm questionnaire. Pre- and post-injury/post-operative SF-36 and IKDC evaluations will be performed to document the patient's objective and subjective complaints. Knee Injury and Osteoarthritis Outcome Score (KOOS), which is specifically used for knee injuries that result in post-traumatic OA, will be evaluated in all subjects, including 5 subscales: pain, other symptoms, function in daily living ADL, function in sports and recreation, and knee-related quality of life. The aim is to demonstrate the feasibility of relating the longitudinally acquired, novel imaging measures to the clinical outcomes as assessed by patient-reported questionnaires, and assess the magnitude and types of OA features developed over time at multiple centers.
Measured: Baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Injury of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Sponsor
- Investigators
- Chunbong B Ma, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010125
- Sponsor's protocol ID
- AFstudy
- Status last verified
- Nov 2018
- First submitted
- 9 Dec 2013
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided at this point. If there are any queries, can contact at maben@ucsf.edu
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Feasibility Trial Establishing Imaging and Biochemical Technologies as Measures of Knee Cartilage Composition Following Acute ACL Injury
- ClinicalTrials.gov ID
- NCT02010125
- Acronym / sponsor ID
- AFstudy
- Keywords
- Anterior Cruciate Ligament (ACL), Magnetic Resonance Imaging (MRI), Osteoarthritis (OA), Bio-specimens, Acute ACL Injury, Arthritis Foundation (AF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and Women with acute ACL injury (within 28 days)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follow patients with acute ACL tears longitudinally using advanced, quantitative morphological MR imaging.
Time frame: Baseline - 12 months
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.
3 secondary outcomes
Collect and store bio-specimens
Time frame: Baseline - 12 months
Functional Assessments
Time frame: 6 months, 12 months
Patient-Reported Questionnaires
Time frame: Baseline - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: Undecided. undecided at this point. If there are any queries, can contact at maben@ucsf.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunbong B Ma, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Injury of Anterior Cruciate Ligament, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow patients with acute ACL tears longitudinally using advanced, quantitative morphological MR imaging. (time frame: Baseline - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.