Pathogen Screening in OA Orthopaedic Surgical Patients

NCT03394170 | Completed

• 1 other identifier: SRF-025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Evidence of oral pathogens in knee joint

  Evidence of specified oral pathogens in the synovial fluid and/or tissue

  2 weeks

Study Arms (2)

Osteoarthritis

Participants who are undergoing unicompartmental knee replacement will be considered OA status

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

Other: Collection of specimens prior to and during surgery

Interventions

Collection of specimens prior to and during surgery OTHER

Collection of specimens prior to and during surgery

Also known as: Specimen collection

Non-Osteoarthritis; Osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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.

Sponsors & Collaborators

• The Stone Research Foundation for Sports Medicine and Arthritis: lead

Study Sites (1)

Stone Research Foundation

San Francisco, California, 94123, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kevin R Stone, MD

  Foundation for Sports Medicine & Arthritis Research (Stone Research Foundation)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: May 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: March 25, 2021

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)