Institutional Review Board, Hospital for Special Surgery
April 26, 2007
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.
300 consecutive fracture patients of the upper or lower extremity will be asked to participate in this study and 100 arthroplasty patients will be used as controls. During the pre-operative visit for medical clearance, blood samples will be collected for a 25(OH)D, CBC, comprehensive metabolic panel (Na, Cl, K, CO2, glucose, BUN, creatinine, total protein, albumin, Ca, alkaline phosphatase, total bilirubin, AST, and ALT), PTH, bone-specific alkaline phosphatase, magnesium, and phosphorus. Urinary N-telopetide levels will also be obtained. Other information to be obtained will include a current list of medications, the brand and dosage of supplements, muscle strength using the Jamar hand dynamometer, and the SF-36 questionnaire. Patients will be stratified using the ASA Physical Status Classification System. Patients who meet the International Society for Clinical Densitometry criteria for bone mineral density testing will receive a DXA during the first 6 weeks of the post-operative period if they have not received a DXA in the past year. A follow-up letter will be sent in the mail to each patient who is vitamin D deficient and further management should be directed to the patientís primary care physician or the metabolic bone team at the Hospital for Special Surgery.
300 surgical patients 55 years of age or older who present to Dr Helfet with trauma of the upper or lower extremity will be identified for this study and 100 patients who present to Dr. Cornell for elective total hip or knee arthroplasty will be used as controls. Dr. Helfetís patients will be further divided into 200 acute fractures (100 high energy fractures and 100 low energy fractures) and 100 non-unions. Patients must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.