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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. 13-060-3 (Dr. Bruce Liang, PI): A Novel Biomarker for Diagnosing and Quantifying Skeletal Injury
Study description not available
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. 18-076-3 (Dr. Mohamad Halawi, PI): Real-Time Three-Dimensional Analysis of Acetabular Kinematics: Bridging the Gap to Patient-Specific Total Hip Replacement
The purpose of the study is to enhance our understanding of hip biomechanics (human structures and movement) during activities of daily living. Three-dimensional motion analysis will be performed in "healthy" volunteers (no history of degenerative disease or functional limitations in the lumbar spine, hips, or knees that may affect normal gait in either lower extremity) and in patients with degenerative joint disease before and after total hip arthroplasty. This knowledge is intended to improve the treatment and outcomes of degenerative disease of the hip.
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. 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. 17-124-3.1 (Dr. Robert Arciero, PI): Mid and Long-Term Outcomes for Patients Treated with Distal Femoral Osteotomy
We are interested in how patients are doing who had distal femoral osteotomy surgery. This knowledge may help to improve the treatment and outcomes of future patients who experience knee malalignment. Therefore, we are conducting a research study and inviting participation from all patients treated by Robert A. Arciero, MD and Thomas M. DeBerardino, MD who had a distal femoral osteotomy 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 DFO 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 adequately characterize the study population and to determine whether there are differences in the distribution of clinical or demographic variables.
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.