Clinical Trials Directory

Trials / Completed

CompletedNCT01006278

Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

Molecular Biomarkers Associated With Degenerative Joint Disease

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Scuderi, Gaetano J., M.D. · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

This investigation describes a novel complex of structural degradation proteins that is associated with pain in individuals with meniscal pathology undergoing arthroscopic partial meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and specific for the painful state compared with similar aged controls. The absence of the complex in asymptomatic controls makes it a useful biomarker for the disease state.

Detailed description

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.

Conditions

Timeline

Start date
2008-01-01
Primary completion
2008-01-01
Completion
2009-03-01
First posted
2009-11-02
Last updated
2009-11-02

Source: ClinicalTrials.gov record NCT01006278. Inclusion in this directory is not an endorsement.