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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative RA | Patients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 90. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks and one year |
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Inclusion Criteria:
Exclusion Criteria:
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.
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
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The study population will comprise of roughly 200 patients with Rheumatoid Arthritis undergoing a total joint replacement.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| Label | URL |
|---|---|
| Hospital for Special Surgery | View source |
| Principal Investigator, Susan Goodman MD | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 2, 2016 | Feb 26, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2017 | Feb 26, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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During surgery, the subjects' surgeon will take samples of the tissue removed as part of their surgery from their joint. Specifically for Total Hip Replacement (THR), the femoral head will be collected intraoperatively from standardized anatomic sites, (fovea and capsular reflection). For Total Knee replacement (TKR), tissue samples of the patella cartilage, distal femur and proximal tibia, and synovium from the suprapatellar pouch will be collected intraoperatively.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |