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Perioperative Flare in RA: Characterization of Clinical and Biological Features

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ClinicalTrials.gov Identifier: NCT02111057
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief 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 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.


Condition or disease
Rheumatoid Arthritis

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Flare in RA: Characterization of Clinical and Biological Features
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Perioperative RA
Patients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 75.



Primary Outcome Measures :
  1. Rate of RA Flare at 6 week post surgery [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Severity and impact of flares 6 weeks and one year post arthroplasty, using the OMERACT PFQs [ Time Frame: 5 weeks ]
    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).


Biospecimen Retention:   Samples With DNA
During surgery, the subjects' surgeon will take samples of the tissue removed as part of their surgery from their joint. Specifically for THR, the femoral head will be collected intraoperatively from standardized anatomic sites, (fovea and capsular reflection). For TKR, tissue samples of the patella cartilage, distal femur and proximal tibia, and synovium from the suprapatellar pouch will be collected intraoperatively.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise of 100 patients with Rheumatoid Arthritis undergoing a total joint replacement.
Criteria

Inclusion Criteria:

  1. Age 18 - 75
  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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111057


Contacts
Contact: Susan Goodman, MD 212-606-1163 goodmans@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Susan M Goodman, MD    212-606-1163    goodmans@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York

Additional Information:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02111057     History of Changes
Other Study ID Numbers: 2014-233
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
Rheumatoid Arthritis
Total Hip Replacement
Flare
Perioperative Outcomes

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases