An observational study in Osteoarthritis, Knee, sponsored by The Stone Research Foundation for Sports Medicine and Arthritis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by The Stone Research Foundation for Sports Medicine and Arthritis · Observational
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.
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:
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →The Stone Research Foundation for Sports Medicine and Arthritis is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Patients attending The Stone Clinic for knee surgery as a result of a recent sports injury or known osteoarthritis can be considered if they fit the inclusion and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who are undergoing unicompartmental knee replacement will be considered OA status
Other: Collection of specimens prior to and during surgery
Participants with an acute injury (occurring no more than 90 days prior to surgery) with no history of knee injury or surgery, will be considered "Non-OA" status
Other: Collection of specimens prior to and during surgery
Collection of specimens prior to and during surgery
Also known as: Specimen collection
Evidence of oral pathogens in knee joint
Evidence of specified oral pathogens in the synovial fluid and/or tissue
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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The Stone Research Foundation for Sports Medicine and Arthritis