Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee
|ClinicalTrials.gov Identifier: NCT01006278|
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : November 2, 2009
|Condition or disease|
Background: Molecular biomarkers associated with knee pain may be useful as diagnostic tools, prognostic indicators, and surrogate endpoints for therapeutic trials. This study describes a novel complex of structural degradation proteins which are present in the knees of patients with meniscal pathology.
Methods: This prospective cohort study included 30 patients with knee pain, mechanical symptoms, and MRI positive for meniscus tear who elected for arthroscopic partial meniscectomy after failing conservative management. Synovial fluid was aspirated at the time of surgery and assayed for a complex of structural degradation proteins by means of heterogeneous ELISA. The results were compared to knee aspirates from 10 asymptomatic volunteers with no pain. The complex was identified by a proteomic analysis of including multiplexed-bead immunoassay, purification by anion exchange and size exclusion chromatography, and mass spectrometry of individual chromatographic fractions.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Molecular Biomarkers Associated With Degenerative Joint Disease|
|Study Start Date :||January 2008|
|Primary Completion Date :||January 2008|
|Study Completion Date :||March 2009|
Surgical group with knee pain
patients 18 years of age or greater with a history of knee pain for more than three but less than six months who failed conservative management with the presence of mechanical symptoms including locking, catching, or giving way; positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and MRI of the knee positive for meniscus tear in a location correlating with physical examination. Exclusion criteria were as follows: the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV; a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006278
|Principal Investigator:||Gaetano J Scuderi, MD||Stanford University|