NCT03394170

Pathogen Screening in OA Orthopaedic Surgical Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: The Stone Research Foundation for Sports Medicine and Arthritis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 etiology, however both result in breakdown of cartilage. Studies have reported the association between chronic or adult periodontal disease (PD), Porphyromonas gingivalis (P. gingivalis), a gram-negative anaerobic bacterium, and rheumatoid arthritis (RA). Whether or not there is an infectious component of osteoarthritis is of significant interest. 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 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. If an association between OA disease status and the presence of one or more pathogens can be confirmed, further studies can be undertaken to investigate the causative nature of oral pathogens in the clinical manifestation of OA, and eventually may lead to development of targeted therapies to prevent or slow the progression of OA. This study will recruit 50 patients with indications for knee surgery, who fit the inclusion/exclusion criteria. Prior to surgery, patients will undergo an Institutional Review Board (IRB) approved informed consent process for in vitro cellular and biochemical characterization of their tissue. Two discreet populations, essentially normal knees and confirmed osteoarthritic knees will be studied. All patients will provide specimens for analysis, to identify the presence of oral pathogens in each participants saliva, synovial fluid and synovium. Evaluation will include identifying the type and concentration of the following perio-pathogenic bacteria that are known to cause periodontal disease: * Aggregatibacter actinomycetemcomitans * Campylobacter rectus * Capnocytophaga species (gingivalis, ochracea, sputigena) * Eikenella corrodens * Eubacterium nodatum * Fusobacterium nucleatum/periodonticum * Parvimonas micra * Porphyromonas gingivalis * Prevotella intermedia * Tannerella forsythia * Treponema denticola

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
OTHER	Collection of specimens prior to and during surgery	Collection of specimens prior to and during surgery

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2018-01-09
• Last updated: 2021-03-25

Locations

1 site across 1 country: United States