Institutional Review Board, Hospital for Special Surgery
October 10, 2014
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Vivian P. Bykerk, BSc, MD, FRCPC
Reena Khianey, MD
Lisa A. Mandl, MD, MPH
Alessandra Pernis, MD
Mark P. Figgie, MD
Michael Manni, PhD
Woelsung Yi, PhD
Uma Chandrasekaran, PhD
Edward F. DiCarlo, MD
Mary Murray-Weir, PT
Dana Orange, MD
Robert Darnell, PhD
Caroline Reidy, MPH
Michael M. Alexiades, MD
David J. Mayman, MD
Ann R. Bass, MD
George Kalliolias, MD, PhD
Researchers at Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis (RA) “flare” or worsening of disease. Specifically this study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is over the course of a year. Eligible participants will be asked a lot of questions about their RA, their mobility, etc.; we will also be drawing blood to better understand a subject’s recuperation from joint replacement surgery.
We hope to learn how to better manage patients with rheumatoid arthritis when having a joint replacement. For example, if RA patients who flare are unable to participate in post-operative physical therapy and do worse one year after total knee replacement and total hip replacement, perhaps 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.
Participation in this study will continue over the course of one year, and involves a total of 4 study visits and 9 phone calls as well as several blood draws. The visits and blood draws will, whenever possible, occur at the time of routinely scheduled visits. Subjects will have the opportunity to discuss any questions with the research team members, their surgeon and/or their treating rheumatologist.
• Age 18 - 75
• No history of anemia
• Patients with Rheumatoid Arthritis undergoing primary total hip or primary total knee replacement surgery
• Satisfy ACR/EULAR 2010 classification criteria and/or the 1987 RA criteria and be diagnosed with RA
• RAPID 3 > 6
• Patients are currently (or within one month of enrollment) treated with either Disease modifying anti-rheumatic drugs (“DMARDs”) or biologics.
Aim #6, the following additional inclusion criteria apply:
- Treatment with a TNF inhibitor at preop visit
- Patient lives in Manhattan, Brooklyn, Queens, or Bronx
1. Diagnosis of any other systemic rheumatic disease (see ICD-9 codes 135.0, 136.1, 274, 279.4, 279.8, 287.0, 446.0, 446.1, 446.2, 446.21, 446.4, 446.7, 447.6, 556, 696.0, 710.0, 710.2, 710.8, 710.9, 711.1, 711.2, 713.3, 713.7, 714.0, 715.0, 716.2, 719.3, 720.0, 720.1, 720.2, 720.8, 720.9, 725)
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.
6. History of anemia by patient report at pre-operative visit.
7. For Aim #6 these apply
• Hgb<9 on day of discharge
• Peri-operative stress dose steroids
Caroline Reidy, MPH