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Sampling Biomarkers in Meniscus Injury to the Knee

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by:
Scuderi, Gaetano J., M.D.
ClinicalTrials.gov Identifier:
NCT00836966
First received: February 2, 2009
Last updated: February 3, 2009
Last verified: February 2009

February 2, 2009
February 3, 2009
June 2006
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00836966 on ClinicalTrials.gov Archive Site
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Sampling Biomarkers in Meniscus Injury to the Knee
Diagnostic Utility of Cytokine Biomarkers in the Evaluation of Acute Knee Pain

The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and it is unknown why only some injuries become painful. 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 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.

Lavage of the operative and contralateral knee for comparison was performed under anesthesia prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the immediate withdrawal into the syringe. Sixteen asymptomatic control subjects also contributed knee samples. The concentrations of 17 inflammatory cytokines/chemokines were measured using a multiplexed immunoassay panel. Pre-operative magnetic resonance imaging findings and cytokine assay results were compared to "gold-standard" intraoperative findings.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

saline lavage from joint space

Non-Probability Sample

68 patients with knee pain < 6 months with either acute or insidious onset who failed conservative management and elected arthroscopy. Adult volunteers with no history of knee pain.

Cartilage Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with knee pain < 6 months with acute onset 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 both32, absence of severe joint space narrowing on plain radiography1 33, and the presence of grade III signal changes on MRI35 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.
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00836966
Scu.Cyt.001
No
Gaetano J Scuderi, MD, Stanford University
Scuderi, Gaetano J., M.D.
Stanford University
Principal Investigator: Gaetano J Scuderi, MD Stanford University
Scuderi, Gaetano J., M.D.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP