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
  Purpose

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
Cartilage Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Utility of Cytokine Biomarkers in the Evaluation of Acute Knee Pain

Resource links provided by NLM:


Further study details as provided by Scuderi, Gaetano J., M.D.:

Biospecimen Retention:   Samples Without DNA

saline lavage from joint space


Enrollment: 73
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836966

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

No publications provided

Responsible Party: Gaetano J Scuderi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT00836966     History of Changes
Other Study ID Numbers: Scu.Cyt.001
Study First Received: February 2, 2009
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 20, 2014