Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

Molecular Biomarkers Associated With Degenerative Joint Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01006278

Enrollment

Registered

2009-11-02

Start date

2008-01-31

Completion date

2009-03-31

Last updated

2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Diseases

Keywords

biomarker, knee arthroscopy, pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Outcome results