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
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
Patients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 75.
- 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.
- 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
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
|Contact: Susan Goodman, MDemail@example.com|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Susan M Goodman, MD 212-606-1163 firstname.lastname@example.org|