Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

NCT01006278 | Completed DMC

• 1 other identifier: Cyt.002
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cartilage Diseases

Keywords

biomarker; knee arthroscopy; pain

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scuderi, Gaetano J., M.D.: lead
• Stanford University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

synovial fluid ananysis

MeSH Terms

Conditions

Cartilage Diseases; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaetano J Scuderi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2009
• Last Updated: November 2, 2009

Record last verified: 2009-10