An observational study in Rheumatoid Arthritis, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Hospital for Special Surgery, New York · Observational
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)
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 162 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will comprise of roughly 200 patients with Rheumatoid Arthritis undergoing a total joint replacement.
Exclusion Criteria:
EXPLANATION OF CRITERIA:
Rheumatoid arthritis 1987 criteria:
radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
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
6 weeks 1
Patients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 90.
Rate of RA Flare at 6 week post surgery
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
Severity and impact of flares 6 weeks and one year post arthroplasty, using the OMERACT PFQs
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).
Time frame: 6 weeks and one year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital for Special Surgery, New York