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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. 07-016-1 (Dr. Martin Freilich, PI): Osteoporosis and bone augmentation/implant outcomes: An observational study
The objective of this study is to utilize a clinical study model to collect descriptive data needed to support the development of future studies that will test the association between specific measures of bone health and the successful integration of new bone from bone augmentation procedures. Postmenopausal women with a wide range of bone health and reduced jaw bone thickness will receive bone augmentation therapy followed by implant and restoration placement, with the specific treatment based upon best clinical judgment. Throughout initial diagnosis, treatment and follow-up, blood makrers will be drawn to assess bone health and its possible association with treatment outcomes. Outcomes will be based upon clinical and radiographic examination, bone health markers and patient interviews.
IRB No. 07-224-2 (Dr. Augustus Mazzocca, PI): The in vitro effect of biomaterials on human osteoblast, tenocytes and chondrocyte cultures
In this study the goal is to evaluate in vitro, biomaterials, using primary osteoblasts, tenocytes and chondrocytes abtained from discarded tissue samples during orthopaedic procedures.
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. 17-070-1 (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. 14-056SF-6.1 (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 Patients 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. 14-057SF-6.1 (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. 14-136CS-6.2 (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. 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.