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Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006278
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanford University
Information provided by:
Scuderi, Gaetano J., M.D.
  Purpose
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.

Condition
Cartilage Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Biomarkers Associated With Degenerative Joint Disease

Resource links provided by NLM:


Further study details as provided by Scuderi, Gaetano J., M.D.:

Biospecimen Retention:   Samples Without DNA
synovial fluid ananysis

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Group 2
volunteer group

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The operative group consisted of 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 including NSAIDs, physical therapy, and activity modification.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006278


Sponsors and Collaborators
Scuderi, Gaetano J., M.D.
Stanford University
Investigators
Principal Investigator: Gaetano J Scuderi, MD Stanford University
  More Information

Responsible Party: Gaetano J Scuderi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01006278     History of Changes
Other Study ID Numbers: Cyt.002
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Scuderi, Gaetano J., M.D.:
biomarker
knee arthroscopy
pain

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Cartilage Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Connective Tissue Diseases