Characterizing Knee Pain and Response to Surgery Using Local Biomarkers - NCT00961623-94305 (Clinical Trial 306379)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306379.aspx
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| City: |
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Stanford |
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State:
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CA |
| Zip Code: |
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94305 |
| Conditions: |
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Inflammation |
| Purpose: |
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The diagnosis and monitoring of clinically-significant pathologies of the knee remains
challenging, and it is unknown why only some injuries become painful or respond to surgical
intervention. The limitations of diagnostic magnetic resonance imaging result in arthroscopy
that is not always beneficial. Elucidation of biochemical pathways underlying pain in this
condition may aid patient selection for surgery and provide pharmacotherapeutic targets.
Cytokines or a novel yet uncharacterized protein may be involved in pain following meniscus
injury and diagnostic cytokine assay may help physicians differentiate patients that may
benefit from arthroscopy from those that may not. Additionally, evaluating post-operative
biochemical profiles may provide a method of monitoring surgical outcome and understanding
post-operative continuation or remission of pain.
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| Study summary: |
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Lavage of the operative and contralateral knee for comparison are performed under anesthesia
prior to arthroscopy by the infusion of 10cc sterile saline into the knee joint followed by
the immediate withdrawal into the syringe, and storage at -80°C in a tube containing a
protease inhibitor. At 12wk post-operative a 10cc lavage is performed on the knee that
underwent surgery. Clinical findings for each sample are quantified using gold-standard
symptom severity questionnaires.
The specimens will be analyzed for 31 potential biomarkers using a multiplexed immunoassay
panel, the results of which will be compared with pre- and post-operative clinical findings
and radiographic imaging. Plans do not currently include microarray analysis, but this may
be later included. |
| Criteria: |
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Inclusion Criteria:
- Adult patients with knee pain (acute or chronic) who had failed conservative
treatment and elected for arthroscopic management.
- Indications for surgery included the presence of mechanical symptoms on history, a
physical examination positive for McMurray's maneuver or joint line tenderness or
both, absence of severe joint space narrowing on plain radiography, and the presence
of grade III signal changes on MRI in an anatomic location consistent with the
history and physical examination.
Exclusion Criteria:
- Less than 18 years old.
- Recent (within three months) intra-articular corticosteroid injection and past or
current medical history of autoimmune disease (i.e., rheumatoid arthritis).
- In addition, no patients involved in a worker's compensation claim or personal injury
litigation were enrolled in the study. |
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| Study is available at: |
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Stanford University School of Medicine
Stanford, CA 94305
United States
Primary Contact:
Eric Leroux
Email: eleroux@stanford.edu
Phone: 917-428-3991
Secondary Contact:
Eric Leroux
Email: eleroux@stanford.edu
Phone: (917) 428-3991 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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