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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006278
Other study ID # Cyt.002
Secondary ID
Status Completed
Phase N/A
First received October 30, 2009
Last updated October 30, 2009
Start date January 2008
Est. completion date March 2009

Study information

Verified date October 2009
Source Scuderi, Gaetano J., M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2009
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Scuderi, Gaetano J., M.D. Stanford University
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