Sampling Biomarkers in Meniscus Injury to the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836966
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 4, 2009
Stanford University
Information provided by:
Scuderi, Gaetano J., M.D.

Brief Summary:
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.

Condition or disease
Cartilage Diseases

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Utility of Cytokine Biomarkers in the Evaluation of Acute Knee Pain
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Biospecimen Retention:   Samples Without DNA
saline lavage from joint space

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836966

Sponsors and Collaborators
Scuderi, Gaetano J., M.D.
Stanford University
Principal Investigator: Gaetano J Scuderi, MD Stanford University

Responsible Party: Gaetano J Scuderi, MD, Stanford University Identifier: NCT00836966     History of Changes
Other Study ID Numbers: Scu.Cyt.001
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases