Pathogen Screening in OA Orthopaedic Surgical Patients

Completed

Conditions studied: Osteoarthritis, Knee

In brief

The purpose of this study is to screen orthopedic surgery patients with and without a diagnosis of osteoarthritis for the presence of 11 pathogens associated with periodontal disease (PD) from a collection of oral rinse, synovial fluid and their synovium. The investigators hypothesize that there is a correlation between the presence of specific oral pathogens in saliva, synovial fluid and synovial tissue with clinical diagnosis of OA.

Key facts

Study ID

NCT03394170

Run by

The Stone Research Foundation for Sports Medicine and Arthritis

People needed

50

Starts

2017-05-01

Expected to finish

2018-07-31

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature (as evidenced by x-ray)
• Aged 18 years or over
• Patient will be undergoing orthopaedic surgery
• If patient is "Non-OA," patient has no history of previous injury / surgery to operative joint
• Patient is able to understand the requirements of the study, abide by the restrictions, and return for all required examinations and treatments.
• Patient is able to give written informed consent

You may not qualify if…

• A clinical diagnosis of inflammatory arthritis made by history, examination or serology.
• An active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated within the previous 3 months.
• A history of chronic alcohol or drug abuse during the six months prior to the study.
• Clinically documented acute or unstable concomitant disease, other than the condition to be treated in this study that might affect make it difficult to interpret the patient's cartilage composition (i.e. renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases).
• Systemic administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immunostimulating or immunosuppressant agents.
• Patients with a medical condition that interferes with their ability to participate in surgery or rehabilitation program.
• Participation in any other investigational drug or device trial during the 30 days prior to screening visit or who will receive such a drug or device during the course of this study.
• Pregnant females.
• Subject's unable or unwilling to comply with the protocol or scheduled appointments.
• Subject's unable to provide informed consent.
• Subject's unable to understand verbal and/or written English.

Where it is running

• Stone Research Foundation — San Francisco, California, United States

Full record on ClinicalTrials.gov

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