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Clinical Trials: Muscle, Bone and Cartilage
IRB No. 03-008-1 (Dr. Ernst Reichenberger, PI): Genetic Analysis of Human Disorders: Skeletal Disorders
The purpose of this study is the investigation of rare bone disorders such as craniometaphyseal dysplasia, cherubism, aplasia cutis congenita, gnathodiaphyseal dysplasia.
IRB No. 06-577-2 (Dr. Augustus Mazzocca, PI): Proximal Humerus and Distal Femur Intramedullary Aspiration During Standard Rotator Cuff or ACL Repair: A Pilot Study.
Use of bone marrow obtained from the pelvis in various orthopedic procedures has been well documented. Less is known regarding bone marrow harvested from the proximal humerus and distal femur. This study has incorporated a method in which bone marrow is harvested at the time of surgery without an increase in surgical procedures. These samples are analyzed in our laboratory to determine if these sites are potential sources of adult stem cells.
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. 14-056-6 (Dr. Pamela Taxel, PI): Investigation of the Ability of the UCONNS (University of Connecticut OsteoNecrosis Numerical Scale) to Predict the Risk for the Developing Osteonecrosis of the Jaw in Women Receiving Bone-Modifying Therapies for Cancer
The purpose of this proposal is to investigate the risk factors for osteonecrosis of the jaw (ONJ), a known complication of several bone-modifying therapies used in the treatment of advanced cancers. When this complication occurs, it can lead to the discontinuation of important therapy that often impacts the quality of life in skeletal-related events in this population. With the use of a weighted scale that we have devised, the University of Connecticut OsteoNecrosis Numerical Scale (UCONNS), based on known risk factors for ONJ, we aim to validate this scale as a potential predictor of patients at risk, so they may be appropriately monitored and preventative treatment can be initiated. As the medical community has limited guidelines regarding ONJ, we anticipate that this scale, if validated, will foster better communication among providers, as well as improve patient outcomes. This proposal represents a unique collaboration between two investigators in the dental and medical schools at the University of Connecticut Health Center. We hypothesize that the UCONNS can aid in the identification of cancer patients who may be at increased risk for the development of ONJ associated with the use of bisphosphonates and the newer bone modifying therapy, denosumab.
IRB No. 14-057-6 (Dr. Pamela Taxel, PI): Investigation of the Ability of the UCONNS (University of Connecticut OsteoNecrosis Numerical Scale) to Predict the Risk for the Developing Osteonecrosis of the Jaw in Women Receiving Bone-Modifying Therapies for Breast Cancer
The aim of this proprosal is to investigate the risk factors for Osteonecrosis of the Jaws (ONJ), a known complication of several bone-modifying therapies including bisphosphonates and denosumab, a human monoclonal antibody. ONJ is most commonly seen with the use of these medications in the treatment of skeletal related events in cancer patients with metastatic bone disease, and less frequently seen in the treatment of osteoporosis. This complication often causes significant effects on quality of life that may lead to the discontinuation of important disease-modifying therapy. We have recently developed the UCONNS (University of Connecticut OsteoNecrosis Scale) a weighted scale based on known medical and dental risk factors for ONJ that we are currently validating both retrospectively and prospectively for use as a potential predictor of patients at risk, so they may be appropriately monitored and preventative treatment can be initiated. The current proposal aims to add to the UCONNS by prospectively measuring serum bone markers that may prove valuable in predicting patients that are at increased risk for developing ONJ. We will follow patients who are being treated with bone modifying agents in order to prospectively measure and evaluate a panel of unique parameters of bone metabolism to identify potentially predictive serum biomarkers for the development of ONJ. We hypothesize that the UCONNS can aid in the identification of breast cancer patients who may be at increased risk for the development of ONJ associated with the use of bisphosphonates and the newer bone modifying therapy, denosumab.
IRB No. 14-136-6 (Dr. Biree Andemariam, PI): Hemoglobinopathies and Bone Health
This research study has two purposes. The first purpose is to determine whether having sickle cell trait is a risk factor for the development of bone thinning at an earlier age than expected. Nearly 10% of African Americans carry sickle cell trait and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. We believe having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to try to understand why individuals with sickle cell disease have thinner bones than healthy individuals do. Doctors have already discovered that people with sickle cell disease have very thin bones, but they have not determined why. Our study will try to identify whether the bone thinning is from the body not making enough bone or from the body losing bone once it is made.
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. 17-024-1 (Dr. Craig Rodner, PI): Clinical and Radiographic Outcome Following Management of Benign Lesions of the Hand and Wrist with Calcium Phosphate Bone Cement
Traditional treatment for benign tumors of the hand and wrist involves curettage to remove the tumor. Following removal, the hand is typically reconstructed with autograft or allograft tissue. Due to concerns of donor site morbidity with autografts and immunogenicity with allografts, there has been a shift towards using various types of bone graft substitute to fill the void after bone tumor removal. Calcium phosphate bone cement is an alternative to allograft or autograft bone following curettage in the treatment of benign hand and wrist tumors. Few studies have reported patient outcomes following treatment with calcium phosphate bone cement grafting following curettage for treatment of enchondroma of the hand and those that have included several patients with pathologic fractures, which required fixation. The purpose of this study is to examine the long-term outcome of patients who were treated with calcium-phosphate bone cement for benign lesions in the hand and wrist without pathologic fractures. This is a one time study visit. Patient reported outcome measures, physical exam finding, and a radiographic assessment will be used to evaluate the success of this procedure.
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. 18-000-3.2 (Dr. Michael Michonski, PI): Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements.
This study is a multi-center, blinded, randomized controlled trial, using a parallel two-arm design to investigate whether long term postoperative antibiotic regimens (5 days) will decrease the rate of infection among patients being surgically treated for a lower extremity bone tumor, when compared to short term postoperative antibiotics (24 hours). We will assess infection rates within 12 months after initial surgery across both study arms. We will measure function and quality of life preoperatively, and at 3 months, 6 months, and 1 year postoperatively.
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.