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Hip Prosthesis Infection clinical trials

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NCT ID: NCT05932823 Completed - Clinical trials for Hip Prosthesis Infection

Does the Type of Ventilation Affect the Risk for Infections After Hip Replacements?

Start date: January 1, 2010
Phase:
Study type: Observational [Patient Registry]

Background: During hip replacement surgery, there is a risk that bacteria in the operating room can cause an infection. To try and reduce this risk, some operating rooms use a special system called laminar airflow (LAF), which reduces the number of bacteria in the air. However, it's not clear if LAF is better than the older system, called turbulent airflow (TAF), for preventing infections. Aim: The aim of this study is to compare the two airflow systems and see if LAF is better at preventing infections after hip replacement surgery. Methods: Information from a database containing all hip replacement surgeries done in Denmark between 2010 and 2020 is examined. The number of infections that occur in surgeries done with LAF, which reduces the number of bacteria in the air during surgery, is compared to the number of infections that occur in surgeries done with TAF. To make the results more credible, the data from the hip register was combined with data from the bacterial cultures taken during surgery. Use and relevance: Infections after hip replacement surgery can be very serious and expensive to treat. Hospitals need to choose the best airflow system to help prevent these infections. This study is important because it gives more accurate information about which system is better at preventing infections and can help hospitals make better choices when they are designing or renovating operating rooms.

NCT ID: NCT05615701 Terminated - Hip Osteoarthritis Clinical Trials

Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

PreHIPEOS
Start date: November 16, 2022
Phase: N/A
Study type: Interventional

EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams. The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose

NCT ID: NCT05000723 Recruiting - Clinical trials for Prosthetic Joint Infection

Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven

PROFITH
Start date: July 14, 2022
Phase:
Study type: Observational [Patient Registry]

Prosthetic Joint Infection (PJI) of a Total Hip Replacement (THR) is a disastrous complication of an otherwise extremely successful surgical procedure. It is associated with a burdensome treatment for the patient, significant challenges for the medical team and high costs for society. As more joint replacements are being performed each year, due to an ageing population and lower thresholds for surgery, the number of PJIs is on the rise. Many of these patients will be referred to University Hospitals Leuven as the physicians have extensive experience with this particular pathology and can offer a multidisciplinary and patient-tailored treatment. Many controversies exist in the field of PJI treatment, both with regard to the surgical aspects as well as the antibiotic treatment. Setting up randomized controlled trials to answer these questions has been proven to be very difficult due to large variations in patients, implants, germs, soft and hard tissues, antibiotic resistance patterns, and so on. Also, surgery for PJIs is usually non-elective / semi-urgent and therefore time to include patients into different trials is limited. Therefore the investigators will prospectively collect data on patients with PJI treated at University Hospitals Leuven, starting 01/01/2022, in order to have knowledge of own results and inform patients about chances of success prior to treatment; perform internal audits and quality checks; answer questions in the field of PJI treatment not suitable for RCTs.

NCT ID: NCT04488458 Recruiting - Clinical trials for Prosthetic Joint Infection

Susceptibility Testing of Biofilm to Guide Treatment of Periprosthetic Joint Infections

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The overall purpose of this clinical treatment research project is to explore novel diagnostics that can guide the treatment of infections associated to orthopaedic implants, in order to improve patient outcomes and reduce the development of antibiotic resistance. The project aims are: (i) To improve the current diagnostic approaches and treatments of periprosthetic joint infections (PJI) (ii) To investigate the pathogenesis of PJI through the characterization of the virulence carried by the causative pathogens This multidisciplinary project addresses implant-associated infection and its contribution to increasing antibiotic resistance. Both lead to longer hospital stays, higher medical costs and increased morbidity and mortality. Antibiotic resistance is globally considered as one of the greatest and most urgent risk in medicine. Implant-associated infections are commonly caused by biofilms. Biofilms can be described as 'a community of bacterial cells connected by their secreted extracellular matrix'. Since antibiotics are designed to fight planktonic free-living bacteria, studying antibiotic resistance in biofilm communities poses a paradigm shift. Furthermore, bacteria in biofilms are up to 1000 times more resistant to antibiotics than planktonic bacteria. Mechanisms involved in a biofilm infection also play a crucial role in the development of antibiotic resistance. Hospital-acquired infections are the fourth leading cause of disease and 70% are associated with medical implants and caused by staphylococcal biofilms. In addition, the level of antimicrobial resistance in bacteria causing implant-associated infections has increased worldwide, leaving patients with fewer treatment options. In this study the investigators will randomize patients with PJI to either standard MIC susceptibility or MIC and MBEC susceptibility guided treatment with oral antibiotic combinations; (i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks. (ii) Or; non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks. In this pilot project, the primary endpoint is how often treatment changes with the MBEC susceptibility testing compared to only MIC-susceptibility testing.

NCT ID: NCT04304885 Recruiting - Joint Infection Clinical Trials

Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

Start date: March 15, 2020
Phase:
Study type: Observational [Patient Registry]

It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.

NCT ID: NCT04251377 Recruiting - Clinical trials for Hip Prosthesis Infection

Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection

SINBIOSE-H
Start date: September 30, 2021
Phase: N/A
Study type: Interventional

Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay. Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm. As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low. We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases. An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA. The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.

NCT ID: NCT04119804 Recruiting - Clinical trials for Hip Prosthesis Infection

Early Discrimination of Periprosthetic Hip Infections Using Neural Networks (SEPTIC-ANNR)

SEPTIC-ANNR
Start date: October 3, 2019
Phase:
Study type: Observational

The study is about the role of cellular neural networks-genetic algorithm in the diagnosis of periprosthetic hip infections. A retrospective case series of septic and aseptic loosening of primary hip arthroplasties is selected. The diagnosis of septic loosening is made according to well-established criteria (CDC 2014 and culture samples). The serial radiographs of the selected patients are processed using cellular neural networks-genetic algorithm. The purpose of this study is to evaluate whether neural networks (cellular neural networks-genetic algorithm), applied to conventional radiographies, are accurate, sensitive and specific for the early-discrimination of a periprosthetic hip infection, already diagnosed with well-recognized methods (CDC 2014).

NCT ID: NCT03389646 Recruiting - Clinical trials for Hip Prosthesis Infection

CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

Start date: September 27, 2017
Phase: Phase 4
Study type: Interventional

Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening. The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication. Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice. Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.

NCT ID: NCT03161990 Completed - Clinical trials for Arthroplasty Complications

DAIR for Infected Total Hip Arthroplasty - Does the Operative Approach Influence the Functional Result?

Start date: April 23, 2018
Phase:
Study type: Observational

The functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown to yield god results with respect to infection control in cases of early infection with a stable implant and better functional results than a to-stage revision. In patients where infection control was achieved after just one DAIR procedure the functional outcome was comparable to an uncomplicated primary arthroplasty. However, it is not known if the operative approach used for the primary and revision surgery plays a role for the functional result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is to investigate if the choice of the operative approach (transgluteal or posterior) for the primary hip replacement and the revision surgery has an influence on the functional result after debridement and implant retention for an infected total hip replacement.

NCT ID: NCT02660268 Recruiting - Clinical trials for Hip Prosthesis Infection

Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections

OSCAR-PH
Start date: March 21, 2016
Phase: N/A
Study type: Interventional

The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.