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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. 17-066-3 (Dr. Augustus Mazzocca, PI): Factors Influencing Successful Non-operative Management of Patients with Acromioclavicular Joint Dislocations
This study will examine the outcomes of patients who had an acromioclavicular (AC) joint dislocation at least two years ago and were initially treated without surgery by Dr. Augustus Mazzocca. A survey will be used to collect updated post-treatment outcome information from patients regarding the current condition, symptoms and functioning of the injured shoulder. A chart review will be conducted to collect demographic and clinical information including injury, treatment and, where applicable, intra-operative details. Retrospective and prospective data will be examined to determine the factors associated with positive outcomes.
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. 18-046-2 (Dr. Robert Arciero, PI): Correlation of the Load and shift Exam Under Anesthesia with On-Track/Off-Track Measurements for Anterior Shoulder Instability: A clinical tool to assess significant bone loss
This study is about a method for doctors to assess significant bone loss and determine the best surgical treatment. It includes a retrospective chart review and prospective data collection from patientswho undergo shoulder surgery using an arthroscopic Bankart repair, open Bankart repair or open Laterjet procedure. When patients undergo this surgery, doctors normally evaluate CT or MRI scans and examine the shoulder by moving it around. The purpose of this study is to collect and compare measurements from the routine scans and physical exam during surgery. Prospective participation in this study involves simply allowing these two measurements, along with age, gender, type of surgery and surgery side to be kept in secure databases (outside of the medical record) and analyzed for this research study.
IRB No. 18-093-1 (Dr. Mohamad Halawi, PI): Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation. Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.
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. 18-001-2 (Dr. Lauren Geaney, PI): Evaluating an Objective Measure of Diagnostic Ankle Arthroscopy Skills
This is a pilot study for a new arthroscopic skill evaluation tool. Participants will be asked to perform an arthroscopic procedure on a cadaver ankle while being observed. Participants will also be asked to answer questions about themselves and their knowledge of orthopedic surgery via a short questionnaire, self-evaluation and oral examination. The single session should last about 30-40 minutes in the arthroscopy teaching laboratory in the Medical Academic Research Building (MARB).
IRB No. 12-065-1 (Dr. Augustus Mazzocca, PI): Outcome Following Reparative, Restorative, and Reconstructive Procedures for the Shoulder
This is an observational study designed to capture the clinical and structural outcome of patients who have undergone a reparative, replacement, or reconstructive procedure for the shoulder.
IRB No. 18-122-2 (Dr. Robert Arciero, PI): Utility of Intraoperative Radiograph to Confirm Position of Suspensory Fixation
Suspensory fixation of anterior cruciate ligament (ACL) graft has emerged as a good option femoral graft fixation. It offers the advantage of technical ease and speed while providing a secure fixation. However, there are numerous examples in the literature of improper deployment of the fixation leading to tissue interposition between the button and bone. A poorly deployed button can cause inadequate fixation, which has been shown to lead to graft migration and pain. Occasionally, revision surgery is required to fix these complications. Despite the documented potential for complication, many surgeons do not confirm the correct position of their fixation with radiograph but instead rely on manual testing for a "hard stop" to confirm positioning. This manual testing is performed by tugging on the graft after the fixation is deployed and considering the button to be in the correct position when there is a hard stop, or no more give to the graft. The authors believe that this commonly employed method may be inadequate to determine correct button position. We believe that, after it appears the button is in a correct position by manual testing, an intraoperative radiograph will often demonstrate tissue interposition between the button and bone.
IRB No. 17-014-3.2 (Dr. Robert Arciero, PI): Mid- and Long-Term Outcomes for Patients Treated with High Tibial Osteotomy
We would like to know more about the outcomes of patients who underwent an arthroscopic high tibial osteotomy (a.k.a. realignment of the knee by cutting the tibia). To better understand the outcomes of this treatment, we are conducting a research study and inviting participation from all patients treated by Dr. Robert A. Arciero who underwent an HTO at least two years ago. This is a case series study with three distinct parts: (1) a limited retrospective chart review, (2) a prospective survey and detailed retrospective chart review for responders, and (3) a detailed retrospective chart review for non-responders. The purpose of the limited retrospective chart review is to collect the minimum information necessary to determine eligibility and to contact eligible patients. Then, eligible patients will be contacted to invite participation in the prospective survey and detailed retrospective chart review. For patients who respond, the survey is used to collect postoperative outcome information regarding current pain, satisfaction and functional outcomes. Patients who respond will also be included in a detailed retrospective chart review to collect information regarding demographics, preoperative clinical factors, radiographs and the HTO procedure in order to examine relationships between preoperative and operative findings as well as the postoperative outcomes collected during the prospective survey. Patients who do not respond by enrollment closure will be considered lost to follow-up. A second detailed retrospective chart review will be performed to include these non-responders in order to adequeately characterize the study population and to determine whether there are differences in the distribution of clinical or demographic variables.
IRB No. 19-006-2 (Dr. Mohamad Halawi, PI): Comparison of home health services versus surgeon-directed home rehabilitation following total joint arthroplasty: a randomized controlled trial.
There is limited prospective research examining clinical outcomes in joint replacement surgery for patients receiving an unsupervised home rehabilitation program. Recent literature suggests that patients experience the same clinical outcomeswhen they perform physical therapy independently at home following a surgeon's direction (surgeon-directed home rehabilitation)compared to their receiving visiting physical therapists at their home (home health services). There is also a dramatic cost benefit from prescribing unsupervised physical therapy. Hypothesis: Surgeon-directed home rehabilitation is clinically non-inferior to home health services while being significantly less costly. Objectives: To assess clinical outcomes, complications, and cost-effectiveness of surgeon-directed home rehabilitation compared with home health services.
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. 19-042-2 (Dr. Augustus Mazzocca, PI): A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Pulsed Electromagnetic Field (PEMF) therapy as an Adjunctive Treatment to the Surgical Repair of Full Thickness Rotator Cuff Tears
The purpose of this research study is to understand if pulsed electromagnetic field (PEMF) therapy with the RCStim device will help reduce tendon re-tear rate, decrease user pain, and increase the range of motion and strength of the shoulder following surgical repair of a full thickness rotator cuff tear.
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.