21 Clinical Trials for Various Conditions
This study will use a 3D scanner to print a 3D model or mold for each patient's prosthesis. The goal of this study to provide patients with a new, faster method of imaging and creating prostheses that preserves the quality of the current method while reducing time spent by both the patient and providers. Patients that are eligible will have a non-invasive 3D scanner (Artec Space Spider) to image the indicated areas of their head and face to help create their new prosthesis. Patients will come in for visits as needed to fit and adjust their prosthetic. Additionally, patients will be asked to complete questionnaires and have follow-up visits at certain time -points pre and post prosthetic completion.
The purpose of the research is to develop a new medical device prototype to restore functional movement of an arm made weak due to a chronic stroke
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.
Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants. The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer typically is left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if the patient requires repeat debridement, a second operative procedure is performed. While the use of an antibiotic-loaded spacer is well accepted, whether the spacer should immobilize the knee (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of articulating spacers argue that they prevent scarring of the musculature surrounding the knee resulting in easier reimplantation, improved long-term knee function, and improved range of motion. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters knee function, operative time, and range of motion. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total knee arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, knee function, ease of reimplantation, and range of motion. The investigators hypothesize that articulating spacers will provide shorter operative times at reimplantation, while improving knee function and range of motion.
Prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. Optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. This procedure is followed by reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. Traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. With this strategy the success rate is close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture fixation device infections conducted in Europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed study will be a prospective open label observational cohort that will evaluate the outcome of Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. This medical regimen was approved for use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. The outcome of this group will be compared to a historical group that is treated with traditional therapy.
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.
This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.
The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are: * Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Infection remains one of the most difficult-to-treat complications of total hip arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants.The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer is typically left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if a second debridement is required, a second operative procedure is performed. While the use of an antibiotic spacer is well accepted, whether the spacer should immobilize the hip (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and that these spacers are simpler to fashion intraoperatively. Proponents of articulating spacers argue that they improve hip function, prevent damage to the musculature surrounding the hip, allow easier reimplantation, improve hip function, and prevent dislocation following hip reimplantation. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters hip function, operative time, and dislocation rates. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total hip arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, hip function, ease of reimplantation, and dislocation rates. The investigators hypothesize that articulating spacers will provide shorter operative times at replantation while improving hip function and hip dislocation rates following hip reimplantation.
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to warfarin.
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range. Patients who require chronic anticoagulation with one or more of the following conditions are eligible for the study: atrial fibrillation or atrial flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial infarction or cardiomyopathy will be enrolled.