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CompletedNCT02111057Updated Oct 21, 2019

Perioperative Flare in RA: Characterization of Clinical and Biological Features

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
162
Ages
18 Years to 90 Years
Sex
All
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Study summary

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)

Read the detailed description

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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Total Hip Replacement
  • Flare
  • Perioperative Outcomes
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In context

Arthritis

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will comprise of roughly 200 patients with Rheumatoid Arthritis undergoing a total joint replacement.

Inclusion criteria

  1. Age >18
  2. Patients with Rheumatoid Arthritis undergoing total joint 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
  4. For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

Exclusion criteria

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.

EXPLANATION OF CRITERIA:

Rheumatoid arthritis 1987 criteria:

  1. morning stiffness in and around joints lasting at least 1 hour before maximal improvement;
  2. soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;
  3. swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;
  4. symmetric swelling (arthritis);
  5. rheumatoid nodules;
  6. the presence of rheumatoid factor; and
  7. 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

  1. have at least 1 joint with definite clinical synovitis (swelling)*
  2. 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

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

    • The criteria are aimed at classification of newly presenting patients. In addition, patients with erosive disease typical of rheumatoid arthritis (RA) with a history compatible with prior fulfillment of the 2010 criteria should be classified as having RA. Patients with longstanding disease, including those whose disease is inactive (with or without treatment) who, based on retrospectively available data, have previously fulfilled the 2010 criteria should be classified as having RA.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
162 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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Study locations

1 site
  • Hospital for Special Surgery
    New York, New York 10021, United States
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References and documents

Study documents

  • Informed consent form · Sep 2, 2016
  • Protocol and statistical analysis plan · Mar 9, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02111057
Lead sponsor
Hospital for Special Surgery, New York
Responsible party
Sponsor
First posted
Apr 10, 2014
Start date
Oct 16, 2013
Primary completion
May 9, 2017
Completion
May 9, 2017
Last update
Oct 21, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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