Hospital for Special Surgery
New York, 10021, United States
NCT Number: NCT02111057
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)
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Notify Me18 year–90 year
All sexes
Observational
New York, 10021, United States
The condition to be studied is worsening (flare) of rheumatoid arthritis (RA) in patients who have undergone arthroplasty. RA patients were recruited prior to elective THA and TKA and prospectively followed. Clinicians evaluated RA clinical characteristics 0-2 weeks before and 6 weeks post surgery. Patients answered questions regarding disease activity including self-reported joint counts and flare status weekly for 6 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EXPLANATION OF CRITERIA:
Rheumatoid arthritis 1987 criteria:
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
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
2-10 large joints 1
1-3 small joints (with or without involvement of large joints) 2
4-10 small joints (with or without involvement of large joints) 3
>10 joints (at least 1 small joint) 5
B. Serology (at least 1 test result is needed for classification)
Negative RF and negative ACPA 0
Low-positive RF or low-positive ACPA 2
High-positive RF or high-positive ACPA 3
C. Acute-phase reactants (at least 1 test result is needed for classification)
Normal CRP and normal ESR 0
Abnormal CRP or abnormal ESR 1
D. Duration of symptoms
< 6 weeks 0
Time frame: 6 weeks
The primary outcome is the rate of RA flare within 6 weeks of surgery as measured by the Outcome Measures in Rheumatoid Arthritis Clinical Trials(OMERACT) flare questionnaire. For comparison, the rate of RA flare at 1 week post surgery is measured.
Time frame: 6 weeks and one year
The OMERACT PFQs include flare intensity, duration of flare, worsening of domains associated with flare (pain, fatigue, stiffness, patient reported tender and swollen joint count, difficulties with coping and participation).
Hospital for Special Surgery, New York
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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