Status:
COMPLETED
Pathogen Screening in OA Orthopaedic Surgical Patients
Lead Sponsor:
The Stone Research Foundation for Sports Medicine and Arthritis
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Brief Summary
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 colle...
Detailed Description
Osteoarthritis (OA) is the most common form of arthritis, affecting over 27 million people in the US. Rheumatoid arthritis (RA), a less common form of arthritis, is believed to differ from OA in its e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03394170
Start Date
May 1 2017
End Date
July 31 2018
Last Update
March 25 2021
Active Locations (1)
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1
Stone Research Foundation
San Francisco, California, United States, 94123