IRB Number: 12155

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.

Principal Investigator

Lisa A. Mandl MD, MPH

Co-Investigators

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

Summary

Target enrollment : 45 patients over 2 years

Inclusion/Exclusion Criteria


Inclusion Criteria
All Subjects:
 Age > 18 yrs
 Cases:
 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

Controls
 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)
Exclusion
 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

Contact Information

Lisa A. Mandl MD MPH
MandlL@hss.edu
212.774.2555