Research

Do SLE patients have more early adverse events within 6 months of THR and TKR?

IRB Number: 13056

Institutional Review Board, Hospital for Special Surgery

November 07, 2013

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

Susan M. Goodman, MD

Co-Investigators

Mark P. Figgie, MD
Michael Alexiades, MD
Lisa A. Mandl MD, MPH
Jordan Roberts
Rebecca Zhu

Summary

404 patients will be reviewed over the course of one year

Inclusion/Exclusion Criteria

Inclusion: all knee and hip replacement subjects coded in the Legacy Dataset as SLE and some knee and hip replacement subjects in the Legacy Dataset coded for osteoarthritis

Exclusion: Total joint arthroplasty due to fracture, self report of any systemic rheumatic disease besides SLE, and ICD-9 codes for any other systemic rheumatic disease or inflammatory disorder. For control subjects: secondary ICD9 code for rheumatoid arthritis.

Contact Information

Susan M. Goodman, MD
GoodmanS@hss.edu
212.606.1163



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