Perioperative Flare in RA: Characterization of Clinical and Biological Features



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:September 2013
End Date:January 2015

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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 next year. We will ask patients about their RA, whether it has gotten worse, and whether
they are able to work with the physical therapist. During the course of this study, we'll be
collecting questionnaires, and we'll be drawing blood to better understand what's going on
with RA and with a patient's recuperation from their joint replacement.

We want to understand whether a flare of RA might affect the outcome of a patient's joint
replacement. We believe this study might show us how to better manage patients with
rheumatoid arthritis following a joint replacement. If RA patients who flare are unable to
participate in physical therapy and do worse after one year after a total hip replacement,
more effective treatment could be developed. The study will also help us to identify early
factors that may influence long-term outcomes of joint replacements in RA patients.

The condition to be studied is worsening (flare) of rheumatoid arthritis (RA) in patients
who have undergone arthroplasty. RA patients undergoing arthroplasty most often have severe,
erosive disease. If the rate of flare approaches the estimated 26% rate suggested in a
previous study for RA patients after arthroplasty (Johnson ACR 2011), this could be of
significance in regards to their long term arthroplasty and disease outcomes. Patients who
flare may not be able to participate in the post-operative rehabilitation thought necessary
for optimal arthroplasty outcomes, and it may be difficult for patients who flare after
discontinuing immunosuppressant medications for surgery to regain remission or low disease
activity. Detailed clinical data collected longitudinally from RA patients with severe
erosive disease undergoing arthroplasty in conjunction with further characterization of the
molecular profile of blood and operative tissue could provide valuable information to inform
best practices for this patient group.

Inclusion Criteria:

1. Age 18 - 75

2. Patients with Rheumatoid Arthritis undergoing primary total hip replacement surgery

3. 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

Exclusion Criteria:

1. Diagnosis of any other systemic rheumatic disease

2. Diagnosis of or crystalline arthropathy.

3. Unable to understand or read English.

4. Unable to follow the study protocol in a reliable manner.

5. Age < 18 or >75.
We found this trial at
1
site
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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mi
from
New York, NY
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