Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

NCT ID: NCT01006278

Last Updated: 2009-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

Brief 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

Cartilage Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Group 2

volunteer group

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Scuderi, Gaetano J., M.D.

OTHER

Sponsor Role: lead

Responsible Party

Stanford University

Principal Investigators

Gaetano J Scuderi, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

Cyt.002

Identifier Type: -

Identifier Source: org_study_id