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NCT02010125 · ClinicalTrials.gov registry record
Feasibility Trial Using Imaging and Biochemical Technologies to Measure Knee Cartilage Composition in Acute ACL Injury
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 89
- Enrollment target
NCT02010125: Completed study, sponsored by University of California, San Francisco.
NCT02010125 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 89 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02010125 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 89 participants
- Enrollment target
Study 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.
Primary Outcome
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 signif
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-12 |
What the finished NCT02010125 record still lists
NCT02010125 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 89 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02010125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02010125 about?
NCT02010125 is a clinical study titled "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 ...
What is the current status of trial NCT02010125?
This trial is currently completed. The enrollment target is 89 participants. The study started on 2013-11. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT02010125?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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