Perioperative Flare in RA: Characterization of Clinical and Biological Features

Completed

Conditions studied: Rheumatoid Arthritis

In brief

Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation. Through this study we aim to describe rates, characteristics, and risk factors of RA flare within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)

Key facts

Study ID

NCT02111057

Run by

Hospital for Special Surgery, New York

People needed

162

Starts

2013-10-16

Expected to finish

2017-05-09

Last updated by the study team

2019-10-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18
• Patients with Rheumatoid Arthritis undergoing total joint replacement surgery
• Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification criteria and/or the 1987 RA criteria (see below) and be diagnosed with RA
• For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

You may not qualify if…

• Diagnosis of any other systemic rheumatic disease
• Diagnosis of or crystalline arthropathy.
• Unable to understand or read English.
• Unable to follow the study protocol in a reliable manner.
• Age < 18 or >75.
• EXPLANATION OF CRITERIA:
• Rheumatoid arthritis 1987 criteria:
• morning stiffness in and around joints lasting at least 1 hour before maximal improvement;
• soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;
• swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;
• symmetric swelling (arthritis);
• rheumatoid nodules;
• the presence of rheumatoid factor; and
• radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
• Criteria 1 through 4 must have been present for at least 6 weeks. Rheumatoid arthritis is defined by the presence of 4 or more criteria, and no further qualifications (classic, definite, or probable) or list of exclusions are required.
• ACR/EULAR 2010 criteria for the classification of RA:
• Table 3. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis
• Target population (Who should be tested?): Patients who
• have at least 1 joint with definite clinical synovitis (swelling)*
• with the synovitis not better explained by another disease
• Classification criteria for RA (score-based algorithm: add score of categories A-D;
• a score of ≥6/10 is needed for classification of a patient as having definite RA
• Score
• A. Joint involvement
• 1 large joint 0

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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