[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hip-prosthesis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hip-prosthesis-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,74,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100562629","phase-2-proof-of-concept-study-to-assess-safety-and-efficacy-of-phage-therapy-in-hip-or-knee-prosthetic-joint-infections-due-to-staphylococcus-aureus-treated-by-dair-100562629",false,"NCT06605651","Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.","A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR","GLORIA","Inclusion Criteria:\n\n1. Male or female ≥ 18 years\n2. Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines\n3. Monobacterial Infection due to S. aureus\n4. Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)\n5. Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR\n6. Indication for Open DAIR decided by the Multidisciplinary Team and\u002For Principal Investigator\n7. S. aureus in joint fluid during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion\n8. Patient with a life expectancy of 1 year or more as determined by the principal investigator.\n9. Females of childbearing potential\u002FSexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable effective method of birth control until 1 month after the last study drug administration.\n10. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)\n\nExclusion Criteria:\n\n1. Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.\n2. Patients who have two planned DAIR in sequence (double DAIR)\n3. Patients with ASA score ≥ 4\n4. Severe sepsis or Septic shock or hemodynamic instability\n5. Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation\n6. Indication for suppressive antibiotherapy\n7. Immunosuppressed patients: Patients having a weakened immune system due to diseases conditions (i.e. genetic disorders, malnutrition) or treatment (i.e. anticancer drugs or organ transplant)\n8. Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C\n9. Previous treatment by bacteriophages\n10. Any known phage allergy and\u002For to its excipients\n11. Elevated ALT or AST above 4 times ULN","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.",[27,28],"Hip Prosthesis Infection","Knee Prosthesis Infection",[30,31,32,33,34,35,36],"Prosthetic Joint Infection","PJI","Bacteriophages","Phages","DAIR","Phage Therapy","Antimicrobials","NOT_YET_RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-06","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2029-09",{"name":47,"class":48},"Phagenix","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100439317","long-term-follow-up-of-patients-with-prosthetic-joint-infection-of-the-hip-treated-at-university-hospitals-leuven-100439317","NCT05000723","Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven","PROFITH","Inclusion Criteria:\n\n* 18 years or older\n* patients diagnosed with PJI of the hip based on EBJIS 2021 criteria\n\nExclusion Criteria:\n\n* Patients unable to provide written informed consent\n* Patients who prefer treatment outside of University Hospitals Leuven\n* Patients with infections of the native hip joint\n* Patients with fracture-related infections (FRI)\n* Patients with uncertain diagnosis of PJI according to the 2021 EBJIS criteria\n* Patient younger than 18 years",{"count":57,"type":21},50,"5 Years","OBSERVATIONAL","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 \u002F 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\u002F01\u002F2022, 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.",[30,27],"RECRUITING","2026-03-12",{"date":65,"type":41},"2026-03-16",{"date":67,"type":41},"2022-07-14",{"date":69,"type":21},"2099-12",{"name":71,"class":72},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":73},"100556635","innovative-technologies-for-salvage-procedures-of-failed-treatments-of-osteoarthritis-biomimetics-solutions-custompn-100556635","NCT06527664","Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)","Innovative Technologies for Cost-Effective Healthcare Delivery for Salvage Procedures of Failed Treatments of Osteoarthritis: Specific Biomimetics Solutions to Reduce a Growing Problem With a High Social and Economic Impact.(CustomPN)","CustomPN","Inclusion Criteria:\n\n* need of custom-made acetabular implant on the basis of CT and X-ray evaluation ()\n* pre-operative CT scan\n* adults patients (minimum age: 18 years)\n* complete medical charts\n* patients' availability\n\nExclusion Criteria:\n\n* oncological reasons for revision\n* other types of revision implant (non custom)\n* inadequate medical chart\n* lack of pre-operative CT scan",{"count":83,"type":21},15,"In this prospective multicenter study, a population of adult individuals consecutively treated for revision hips, requiring a custom-made acetabular implant for non-oncological reasons, will be included. The custom-made implant is a personalized implant produced using additive manufacturing, based on the pre-operative CT scan that details the bone damage. Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls).\n\nPreoperatively, the patient will undergo a clinical evaluation. Data will be collected on the patient's general health status with the Charlson score, the reason for revision, number of revisions, type of implant in place, and the time elapsed between the failed implant and the revision in question. The bone deficit will be studied through CT measurements according to qualitative and quantitative scales. During the surgery, information on intraoperative complications will be collected. In the postoperative period, perioperative complications will be collected according to the Clavien Dindo classification. The clinical radiographic evaluations will be carried out during outpatient follow-up visits at 1, 3, 12, 24, and 36 months after revision. They include the Harris Hip Score clinical score, the EQ-5D PROM, and the patient's satisfaction level (qualitative assessment in 4 grades: unsatisfied, slightly satisfied, moderately satisfied, fully satisfied). The positional parameters of the implant will be evaluated, as compared to the immediate post-operative X-ray: acetabular abduction, acetabular anteversion, center of rotation height, center of rotation medialization, and inclination of the custom-made component. From 12 months onwards, the osteointegration characteristics of the component will be assessed: presence of radial trabeculae at the interface, superolateral and inferior reinforcements, stress shielding, absence of radiolucent lines. Re-revision rates will be determined using the Kaplan-Meier method. The reasons for re-revision will be noted.",[86,27,87],"Bone Loss","Arthroplasty Complications",[89,90,91],"revision hip arthroplasty","custom-made implant","additive manufacturing","2026-02-19",{"date":94,"type":41},"2026-02-23",{"date":96,"type":41},"2024-10-01",{"date":98,"type":21},"2026-09-30",{"name":100,"class":72},"Istituto Ortopedico Rizzoli",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":73},"100562489","clinical-evaluation-and-cost-effectiveness-analysis-of-3d-digital-surgery-in-traumatology-100562489","NCT06603831","Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology","Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery","Inclusion Criteria:\n\n\\- Patients that requires one of the following surgical procedures \u002F interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.\n\n-Patients that can understand the clinical study and that are able to read, understand and sign the consent form\n\nExclusion Criteria:\n\n* Patients that are not able to read, understand or sign the consent form.\n* Patients that can't or have no support to complete the clinical trial.\n* Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment","80 Years",{"count":110,"type":21},180,[112],"NA","Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.",[115,116,117,118,119,120,121,122,27,123,124,125],"Radius; Deformity","Hip Osteoarthritis","Hip Arthritis","Hip Arthropathy","Spine Injury","Radius; Anomaly","Vertebra; Degeneration","Vertebral Fracture","Spinal Fusion","Spine Osteoarthritis","Spinal Deformity","2024-11-08",{"date":128,"type":41},"2024-11-12",{"date":130,"type":41},"2024-10-21",{"date":132,"type":21},"2027-12-31",{"name":134,"class":72},"Corporacion Parc Tauli"]