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Biomarkers in Spondyloarthropathies: A Case Control Study

IRB Number: 2014-240
not enrolling new patients

November 16, 2012

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Lisa A. Mandl MD, MPH


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

Inclusion/Exclusion Criteria

Inclusion Criteria
All Subjects:
• 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

Contact Information

Lisa A. Mandl MD MPH