Institutional Review Board, Hospital for Special Surgery
November 16, 2012
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 Bykerk, BSc, MD, FRCPC
Steven Goldring, MD
Ed Purdue, PhD
Mark P. Figgie, MD
Michael Alexiades, MD
Thomas Sculco, MD
Eduardo A. Salvati, MD
Edward F. DiCarlo, MD
Alejandro Gonzalez Della Valle, MD
Gerald Nabozny, PhD
Sudha Visvanathan, PhD
Daw-Tsun Shih, PhD
Target enrollment : 45 patients over 2 years
• Age > 18 yrs
• Patients with psoriatic arthritis or ankylosing spondylitis undergoing total hip replacements
• Satisfy either ASAS or Caspar criteria (see below), or be diagnosed with SPA and treated with DMARDS/biologics by a rheumatologist.
• Onset of symptoms < 45 yrs
• Patients with osteoarthritis undergoing second primary total hip replacement
o All must have had a previous contralateral hip replacement
o Half will have evidence of HO on their previous THA ( HIGH risk for excess bone formation)
o Half will have NO evidence of HO on their previous THA ( LOW risk for excess bone formation)
• Diagnosis of any systemic rheumatic disease or crystalline arthropathy
• Unable to understand or read English.
• Unable to follow the study protocol in a reliable manner
Lisa A. Mandl MD MPH