Institutional Review Board, Hospital for Special Surgery
September 04, 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.
Adhesive capsulitis (frozen shoulder) is a self limiting disease that goes through four stages as it progresses. This study aims to quantify the growth of a cell, called the myofibroblast, which is associated with the disease. We will correlate the number of myofibroblast cells with the stages of the disease. Tissue samples from patients with the diagnosis of adhesive capsulitis will be obtained during arthroscopic surgery. These samples will be compared samples from patients without adhesive capsulitis. A computer program will be used to count the number of myofibroblasts in the tissue samples. This study will allow us to further understand the development of the disease and improve future treatment.
Study patients will be excluded if there is the presence of another shoulder injury or if they have have had previous shoulder surgery on the same side.
Presence of current or previous adhesive capsulitis.
We will analyze the results of the two groups combined and separately.
Jo A Hannafin, MD