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Clinical Trials: Joint/Rheumatoid
IRB No. 08-207-2 (Dr. Robert Arciero, PI): Multi-Center ACL Revision Study (MARS)
This is a multi-center, prospective, longitudinal, outcomes study with an invisted cohort group of participants undergoing ACL revisions, elective, standard of care (SOC) orthopedic knee surgery. Predictors of outcomes (QOL and premature osteoarthritis) have yet to be determined. The American Orthopaedic Society for Sports Medicine have set up, this multi-center evidenced based registry to recruit approximately 1,200 participants who will be followed out for 2-3 years.
IRB No. 11-151-2 (Dr. Vincent Williams, PI): Hip and Knee Outcome Registry
Patients that have their hip or knees replaced by Dr. Williams or Dr. Lindsay have the option to enroll in the registry.
IRB No. 17-070-1 (Dr. Robert Arciero, PI): Mid and Long Term Outcomes of Anterior Shoulder Instability after Arthroscopic Stabilization
The purpose of this study is to assess outcomes at 5 years or more in patients who have undergone an arthroscopic stabilization for symptomatic unidirectional anterior shoulder instability. A survey will be used to collect updated postoperative outcome information from patients regarding current pain, satisfaction and functional outcomes. A chart review will be conducted to collect demographic, injury and perioperative details. These factors will be combined to examine correlations with outcomes.
IRB No. 18-082-2 (Dr. Anthony Parrino, PI): Early Mobilization After Thumb (Carpometacarpal) Arthroplasty
The purpose of this research study is to determine the best post-operative therapy after a thumb (carpometacarpal or CMC) arthroplasty. Patients are currently placed in a thumb splint for 4 weeks after their thumb surgery. However, new research has questioned whether 4 weeks of splinting is needed. Our study will compare patients’ outcomes between 2 groups. One group will be placed in a splint for approximately 10 days after surgery and the other group will be in a splint for the normal duration after surgery (about 4 weeks).
IRB No. 17-155-3 (Dr. Adam Lindsay, PI): Fundamentals of Orthopaedic Surgery (FORS) & Fundamentals of Arthroscopic Techniques (FAST) Surgical Simulators
The purpose of this research study is to evaluate two surgical simulators as a way of assessing and improving surgical skills. The simulators are composed of materials founds at hardware stores such as PVC pipes, pipe insulation, foam bricks and wood blocks. Participants will be asked to perform different surgical skills such as suturing, drilling and/or arthroscopy using one or both of the simulators while being observed. Participation involves multiple 20-30 minute testing sessions to evaluate surgical skills over time. The following individuals are invited to participate in this study: • All UConn Medical Students • All UConn Medical Residents • All UConn Medical Fellows • Attending Physicians that perform more than 5 orthopaedic surgery/arthroscopic operations per month
IRB No. 19-036-1 (Dr. Jun Lu, PI): Rheumatology-Dermatology Combined Clinic Patient Registry
The Rheumatology-Dermatology Combined Clinic Patient Registry is a prospective registry that collects patient data within the UConn Department of Dermatology combined clinic for patients being treated for both rheumatologic and dermatologic conditions. Both dermatologists and rheumatologists participate in care for patients suffering from connective tissue disease with both cutaneous and rheumatological manifestations. By establishing combined rheumatology-dermatology clinic, patients will receive collaborative care from both specialties in the same visit. The combined multidisciplinary clinic offers the opportunity for improving care quality, patient satisfaction, and continued education and professional development for physicians. The protocol includes patients over the age of 18 that are being treated in the UConn combined rheumatology-dermatology clinic. This registry will gather data over a 10 year period for future research regarding improving patient care, diagnosis, treatment and long term outcomes for this subspecialty clinic.
IRB No. 19-098-2 (Dr. Lauren Geaney, PI): Range of motion in Achilles tendinitis predicts success with conservative treatment
Dr. Lauren Geaney and Dr. Vinayak Sathe are conducting a research study to better understand which patients are more likely to succeed with physical therapy for the treatment of chronic Achilles tendinitis. The study is titled, "Range of motion in Achilles tendinitis predicts success with conservative treatment." The investigators believe that patients with good initial ankle range of motion do not have the same success with physical therapy as patients with poor range of motion. Therefore, it is also believed that this association may predict which patients may go on to require surgery. Participation in this study involves completing a few short surveys during three to four regularly scheduled clinic visits before and after physical therapy. These surveys focus on general health and well-being, foot function and pain. Some study data will also be collected from the medical record. There will be no changes in the treatment plan or recommendations for patients who participate in this study.
IRB No. O19-030-2 (Dr. Robert Arciero, PI): The STaR Trial - Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial
The purpose of the STaR Trial is to look at the best way to treat people with a multiple ligament knee injury. A multiple ligament knee injury is an injury in which two or more of the major ligaments in the knee are completely torn. This study is looking at when is the best time to do surgery and when is the best time to start rehabilitation after surgery. More specifically, it is interested in determining the effects of early versus delayed surgery and early versus delayed post-operative rehabilitation for the treatment of multiple ligament knee injuries on return to pre-injury activity. This study will determine how the timing of surgery and rehabilitation affect when someone with a multiple ligament knee injury is able to return to their pre-injury level of activity, whether it’s for work or sports activity. Researchers will follow participants' recovery and return to activity for 24 months. During this time, researchers will record information from participants' routine clinical visits and send questionnaires to participants' to track their progress and return to activity that can be completed on a smartphone or computer.
IRB No. 20-210S-1 (Dr. Nathaniel Rickles, PI): The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
This study is looking at how the packaging of opioid medication affects the use of opioids following surgery. The study is comparing opioid use when provided in a standard amber vial (normal orange bottle) versus a blister pack called the Opioid Package Prototype, or “OPP” for short. Study participants will receive their post-surgery opioid medication from Arrow Pharmacy (located in the Outpatient Pavillion) in one of the two packages, which are pre-assigned. Participants will also complete surveys and/or interviews before surgery and at 1 week, 1 month and 3 months after surgery. Basic criteria to participate include being an adult having one of 17 common surgical procedures by a participating orthopaedic surgeon and using opioid medication for post-operative pain.