This study is to assess the effectiveness of a study medication not approved by the FDA for this use FX006 (Zilretta) on pain, disability, function, and global impression of change in patients who are 35 to 80 years of age who have been diagnosed with glenohumeral osteoarthritis of the shoulder or shoulder adhesive capsulitis. Glenohumeral osteoarthritis (shoulder arthritis) is the most common form of arthritis to affect the shoulder joint. Adhesive capsulitis (frozen shoulder) is a painful and disabling disorder of unclear cause in which the shoulder capsule, the tissue surrounding the joint of the shoulder, becomes inflamed and stiff, greatly restricting motion and causing chronic pain. Zilretta has only been approved by the Federal Drug Administration to treat patients with osteoarthritis of the knee. Subjects who qualify for all of the study criteria will receive an injection using a needle that is guided by an ultrasound and is put into the shoulder joint of either FX006 or placebo (a saline injection) in their effected shoulder and will come to the clinic to be seen for 7 follow up study visits for 24 weeks after the injection. There are a total of 9 clinic visits throughout the study and subjects will also complete an electronic study diary daily to assess shoulder pain and function.
ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.
Patients of age ?50 to <85 years diagnosed with a rotator cuff tear (with MRI confirmation) who are fit for either arthroscopic rotator cuff surgery or physical therapy will be recruited. The study will compare pain and function in patients undergoing operative versus non-operative treatment of Non traumatic rotator cuff tears at 12 months of follow-up.
The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).
This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.
This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.
This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.
Patients who present with a native joint complaint and consent for the study will be tracked and their standard of care data will be monitored for outcomes of a septic joint. There are no additional actions taken outside of the standard of care. The results after the subject goal has been met will allow us to have a better understanding of the criteria for a septic joint.
PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin plus air pump compression, low intensity warfarin, and rivaroxaban.
To collect data to further affirm the safety and effectiveness of the hip replacement systems manufactured and/or dustrubuted by Exactech, Inc. Data will be collected in order to provide post-market subjective and objective evidence of safety and effectivenss. Data may be analyzed to support future presentation and publication of theses systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the devices.
The study will collect data to further affirm the safety and effectiveness of the Optetrak® Knee System product lines. Data will be collected in order to provide post-market subjective and objective evidednce of safety and effectivness. Data may be analyzed to support future presentation and publication of the Optetrak® Knee Systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the Optetrak Knee devices.
The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.
The Systemic Lupus Erythematosus (SLE) in Gullah Health, or SLEIGH, study is an observational study enrolling African Americans from the Sea Island communities of South Carolina and Georgia. We are enrolling patients, family members of patients, and unrelated community members. SLE is a potentially severe disease that can affect the entire body. SLE is more common in African Americans than Caucasians. The main purpose of this study is to find genes that, along with factors from the environment, result in the development of SLE. Volunteers in SLEIGH will be asked to answer questions about their health and have blood and urine collected for tests. After the first visit there may be one additional visit 2 or more years later. This is not a drug study.