September 27, 2006
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.
Mathias P. Bostrom, MD
Bryan J. Nestor, MD
David J. Mayman, MD
Carolyn M. Sofka, MD
Cementless femoral fixation using a flat, wedge-shaped, proximally coated implant has had excellent clinical results over the last 15 years. The benefits of such an implant are: ease of insertion, conservation of bone, and implant stability. We propose the evaluation of a new flat, wedge-shaped implant called the Anthology™ (Smith &Nephew, Memphis, TN), using radiostereometric assay (RSA). RSA is a radiographic technique developed in Sweden that is extremely precise, allowing investigators to track implant movements as small as 200 microns. We propose the evaluation of 30 patients undergoing THR with the Anthology stem, using RSA. The enrollment period will continue until sufficient patients are in the study; follow-up for the study is performed over 2 year period.
Only patients undergoing unilateral, cementless, primary total hip replacement with metal-on-poly bearing will be eligible for this study. Only patients undergoing primary total hip replacement for osteoarthritis will be included.
Other inclusion criteria are: age between 18 and 80 years; body weight less than 100 kg; and ability to understand the purpose of the study and provide consent.
Exclusion criteria are: neoplastic or metabolic bone disease; osteoporosis; inflammatory arthritis; and a history of hip infection or prior surgery.
Basem Aziz
212.606.1713