Osteoarthritis, KneeNCT03394170
Pathogen Screening in OA Orthopaedic Surgical Patients
An observational study of Osteoarthritis, Knee, run by The Stone Research Foundation for Sports Medicine and Arthritis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Collection of specimens prior to and during surgery
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stone Research Foundation
San Francisco, California, 94123
About this study
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.
Read the 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
- Being tested
- Collection of specimens prior to and during surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of specimens prior to and during surgeryOther
Also called Specimen collection
Collection of specimens prior to and during surgery
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis | Participants who are undergoing unicompartmental knee replacement will be considered OA status Receives: Other: Collection of specimens prior to and during surgery | |
| Non-Osteoarthritis | 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 Receives: Other: Collection of specimens prior to and during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of oral pathogens in knee joint
Evidence of specified oral pathogens in the synovial fluid and/or tissue
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 May 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Stone Research Foundation for Sports Medicine and Arthritis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin R Stone, MD, Principal investigator, Foundation for Sports Medicine & Arthritis Research (Stone Research Foundation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394170
- Sponsor's protocol ID
- SRF-025
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen Screening in OA Orthopaedic Surgical Patients
- ClinicalTrials.gov ID
- NCT03394170
- Acronym / sponsor ID
- SRF-025
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Stone Research Foundation for Sports Medicine and ArthritisUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis | – | Other: Collection of specimens prior to and during surgeryParticipants who are undergoing unicompartmental knee replacement will be considered OA status |
| Non-Osteoarthritis | – | Other: Collection of specimens prior to and during surgeryParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of specimens prior to and during surgeryAlso: Specimen collectionCollection of specimens prior to and during surgery | Other | Non-Osteoarthritis, Osteoarthritis |
Primary outcome
Evidence of oral pathogens in knee joint
Time frame: 2 weeks
Evidence of specified oral pathogens in the synovial fluid and/or tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin R Stone, MD principal investigator
Foundation for Sports Medicine & Arthritis Research (Stone Research Foundation)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by The Stone Research Foundation for Sports Medicine and Arthritis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of oral pathogens in knee joint (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.