[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hip-arthroplasty-total\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hip-arthroplasty-total":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,70,95,119,151,181,204,236,256,273,306],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644066","penglfcn-block-vs-qipb-for-total-hip-arthroplasty-100644066",false,"NCT07667231","PENG+LFCN Block vs QIPB for Total Hip Arthroplasty","Comparison Between Quadro-iliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve Block for Total Hip Arthroplasty: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* American Society of Anesthesiologists physical status I-III\n* Scheduled for elective unilateral primary total hip arthroplasty\n* Surgery planned under spinal anesthesia\n* Ability to understand and use the Numeric Rating Scale\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Refusal to participate\n* Revision total hip arthroplasty\n* Bilateral total hip arthroplasty\n* Contraindication to spinal anesthesia\n* Contraindication to peripheral nerve block\n* Known allergy to local anesthetics or study drugs\n* Coagulopathy or anticoagulant use incompatible with neuraxial\u002Fregional anesthesia\n* Infection at the block injection site\n* Pre-existing neurological deficit involving the operative lower extremity\n* Peripheral neuropathy\n* Chronic opioid use\n* Cognitive impairment or inability to communicate reliably\n* Severe hepatic or renal failure\n* Body mass index \\>35 kg\u002Fm²\n* Pregnancy","ALL","18 Years","80 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve(LFCN) block in patients undergoing total hip arthroplasty. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.",[27,28,29,30,31],"Quadro-Iliac Plane Block","Pericapsular Nerve Group Block (PENG Block)","Hip Arthroplasty, Total","Pain Management","Lateral Femoral Cutaneous Nerve Block",[33,34,35],"QIPB","PENG","LFCN","NOT_YET_RECRUITING","2026-06-20",{"date":39,"type":40},"2026-06-25","ACTUAL",{"date":42,"type":21},"2026-11-15",{"date":44,"type":21},"2027-09-15",{"name":46,"class":47},"Antalya City Hospital","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":69,"locationsCount":4},"100644181","comparison-between-quadro-iliac-plane-block-qipb-and-supra-inguinal-fascia-iliaca-compartment-block-s-ficb-for-total-hip-arthroplasty-100644181","NCT07667218","Comparison Between Quadro-iliac Plane Block (QIPB) and Supra-Inguinal Fascia Iliaca Compartment Block (S-FICB) for Total Hip Arthroplasty","Comparison Between Quadro-iliac Plane Block (QIPB) and Supra-Inguinal Fascia Iliaca Compartment Block (S-FICB) for Total Hip Arthroplasty: a Randomized Controlled Trial",{"count":20,"type":21},[24],"This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the supra-inguinal fascia iliaca compartment block (S-FICB) in patients undergoing total hip arthroplasty.\n\nThe primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.",[27,58,29,30],"Supra-inguinal Fascia Iliaca Block",[60,61,62,63,64],"QİPB","S-FICB","HİP","PAİN","ARTHROPLASTY",{"date":66,"type":40},"2026-06-24",{"date":42,"type":21},{"date":44,"type":21},{"name":46,"class":47},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100631283","prp-injection-into-the-sacroiliac-joint-after-ipsilateral-tha-effects-on-early-recovery-and-function-sij-tha-randomized-trial-100631283","NCT07498660","PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)","Effect of Platelet-Rich Plasma Injection Into the Sacroiliac Joint After Ipsilateral Total Hip Arthroplasty on Early Rehabilitation and Patient Function: A Randomized Trial (SIJ-THA Trial)","Inclusion Criteria:\n\n* primary osteoarthritis of the hip;\n* qualification for elective total hip arthroplasty (THA);\n* age ≥45 years;\n* written informed consent;\n* ability to understand Polish.\n\nExclusion Criteria:\n\n* prior surgical treatment of the hip or sacroiliac joint;\n* malignancy;\n* developmental dysplasia of the hip;\n* rheumatologic diseases (rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis);\n* neurological or psychiatric disorders;\n* allergy to local anesthetics.","45 Years",{"count":20,"type":21},[24],"The study is an interventional, randomized, open-label (non-blinded), placebo-controlled trial. Preoperatively, patients scheduled for primary total hip arthroplasty (THA) will undergo a clinical examination in the Orthopaedic Department. Clinical tests will be performed to confirm sacroiliac joint (SIJ) dysfunction on the operated side. In addition, low-dose computed tomography (CT) will be used to assess structural changes in the SIJ.\n\nAll patients will complete patient-reported outcome measures related to the hip joint, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Harris Hip Score (HHS), as well as SIJ-related assessments, including the Oswestry Disability Index (ODI). Pain intensity will be assessed using the Visual Analogue Scale (VAS).\n\nFollowing THA, patients will be randomly allocated into two groups during their hospital stay. In the intervention group, platelet-rich plasma (PRP) will be injected into the sacroiliac joint, whereas the control group will receive an injection of normal saline. All injections will be performed in the operating theatre.\n\nAt discharge, patients will be scheduled for follow-up visits at 2, 6, and 12 weeks postoperatively. At each follow-up, patient-reported outcomes will be collected, including WOMAC and HHS for hip function, ODI for SIJ-related disability, and VAS for pain assessment of both the hip and sacroiliac joint.",[82,83,29,84],"Osteoarthitis","Sacro Iliac Joint Pain","Sacro-Iliac Spondylosis","2026-03-23",{"date":87,"type":40},"2026-03-27",{"date":89,"type":21},"2026-04-01",{"date":91,"type":21},"2028-03-31",{"name":93,"class":47},"Medical University of Warsaw",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100614306","phase-4-the-effect-of-reversal-of-remimazolam-sedation-with-flumazenil-on-cognitive-function-in-patients-undergoing-hip-arthroplasty-under-spinal-anesthesia-100614306","NCT07277881","The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia","Inclusion Criteria:\n\n* Patient qualified for elective, primary, unilateral, total hip replacement.\n* Patient assessed on the ASA I-III scale.\n* MoCA score obtained during screening ≥ 23 points (to exclude patients with significant pre-existing cognitive impairment).\n* Ability to understand information about the study and express informed, written consent to participate.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to benzodiazepines, flumazenil, local anesthetics\n* Contraindications to spinal anesthesia or patient refusal of this anesthesia technique.\n* Severe liver dysfunction.\n* History of epilepsy or seizures\n* Chronic (daily use for \\> 2 weeks in the last 3 months) use of benzodiazepines or non-benzodiazepine hypnotics (so-called \"Z\" drugs: zolpidem, zopiclone, zaleplon).\n* Alcohol abuse defined as regular consumption of more than: in men: 40 g of pure ethanol at a time; in women: 20 g of pure ethanol at a time, or a history of psychoactive substance dependence.\n* Planned revision hip arthroplasty or bilateral surgery.\n* Significant neurological or psychiatric diseases that may affect the assessment of cognitive function.\n* The need for sedative premedication.",{"count":102,"type":21},150,[104],"PHASE4","This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are:\n\n* Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo?\n* Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium.\n\nParticipants will:\n\n* Undergo a planned total hip replacement surgery under spinal anesthesia.\n* Receive sedation with remimazolam during the operation.\n* At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo.\n* Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery.\n* Complete a questionnaire about their quality of recovery (QoR-15).",[107,108,109,29],"Postoperative Delirium","Sedation","Remimazolam","2026-01-01",{"date":112,"type":40},"2026-01-06",{"date":114,"type":21},"2026-01",{"date":116,"type":21},"2028-10",{"name":118,"class":47},"Medical University of Gdansk",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100590771","haka-routine-follow-up-at-1-year-after-hip--or-knee-arthroplasty-wasting-resources-or-appropriate-healthcare-100590771","NCT06971757","HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?","Cost-effectiveness of Routine Follow-up at One Year After Total Hip and Knee Arthroplasty Compared to Check-up on Demand: a Multicenter Hybrid Stepped-wedge Cluster De-implementation Study","HAKA 1year FU","Inclusion Criteria:\n\n* Painful and disabled hip or knee joint resulting from osteoarthritis\n* Scheduled for primary THA or TKA surgery\n* Age 50 years or older at the time of THA or TKA\n* Capable and willing to complete questionnaires\n* Proficient in Dutch or English\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Other indication for surgery than osteoarthritis\n* Scheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty\u002Fresurfacing to THA\n* Already participating in this study due to a previous hip or knee surgery","50 Years",{"count":129,"type":21},1000,[24],"After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.\n\nThe HAKA trial consists of three different work packages (WPs). This trial (WP1) investigates the 1-year follow-up, WP2 examines the 10-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.",[29,133],"Knee Arthroplasty, Total",[135,136,137,138,139],"total hip arthroplasty","total knee arthroplasty","follow-up","PROMIS physical function","healthcare consumption","RECRUITING","2025-11-14",{"date":143,"type":40},"2025-11-18",{"date":145,"type":40},"2025-07-01",{"date":147,"type":21},"2029-12-31",{"name":149,"class":47},"JointResearch",9,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":94},"100591607","supra-inguinal-fascia-iliaca-block-as-rescue-analgesia-following-total-hip-arthroplasty-100591607","NCT06982625","Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty","SOSBIFSI","Inclusion Criteria:\n\n* patient scheduled for a primary total hip arthroplasty under general anesthesia,\n* written informed consent.\n\nNon inclusion criteria:\n\n* contra indication to ropivacaine\n* vulnerable person\n\nExclusion Criteria:\n\n* per-operative complication making wheight-bearing and walking contra-indicated.\n* patient without significant pain post-operatively.",{"count":159,"type":21},310,[24],"Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.\n\nAlthough generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.\n\nIn other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.\n\nA recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.\n\nWhen performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.\n\nIn order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.\n\nIn conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.\n\nNo new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.",[29,163,164],"Post Operative Pain, Acute","Nerve Block",[166,167,168,169,170,171,172],"Total hip arthroplasty","Regional anesthesia","Nerve blocks","Supra-inguinal fascia iliaca block","Enhanced recovery after surgery","Acute post-operative pain","Rescue analgesia","2025-09-22",{"date":175,"type":40},"2025-09-25",{"date":173,"type":40},{"date":178,"type":21},"2027-12-31",{"name":180,"class":47},"Institut Mutualiste Montsouris",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":202,"locationsCount":94},"100598367","haka-routine-follow-up-at-10-years-after-hip--or-knee-arthroplasty-wasting-resources-or-appropriate-healthcare-100598367","NCT07070570","HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?","HAKA 10 years","Inclusion Criteria:\n\n* Underwent primary THA or TKA approximately 10 years ago\n* Age 50 years or older at time of THA or TKA\n* Capable and willing to complete questionnaires (when applicable)\n* Understanding Dutch or English\n* Willing to provide written informed consent in case the patient will complete questionnaires\n\nExclusion Criteria:\n\n* Other indication for surgery than osteoarthritis\n* Deceased\n* Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty\u002Fresurfacing to THA\n* Already participating in this study due to another hip or knee surgery",{"count":189,"type":21},1500,[24],"After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.\n\nThe HAKA trial consists of three different work packages (WPs). This trial (WP2) investigates the 10-year follow-up, WP1 examines the 1-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.",[29,133],[194,195],"Routine follow-up","Check-up on demand","2025-07-14",{"date":198,"type":40},"2025-07-17",{"date":200,"type":21},"2025-09-01",{"date":147,"type":21},{"name":203,"class":47},"Reinier Haga Orthopedisch Centrum",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":94},"100596136","perceptions-of-de-implementing-routine-follow-ups-after-hip-and-knee-arthroplasty-100596136","NCT07041528","Perceptions of De-implementing Routine Follow-ups After Hip and Knee Arthroplasty","How Do Patients and Health Care Professionals Perceive De-implementation of Routine Follow-ups After Total Hip and Knee Arthroplasty? Protocol for a Nested Qualitative Study Within a Hybrid De-implementation Trial","HAKA-QUALI","Inclusion Criteria:\n\n• A good command of the Dutch language\n\nExclusion Criteria:\n\n* N\u002FA",{"count":213,"type":21},90,"OBSERVATIONAL","After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guidelines. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.\n\nThe HAKA trial consists of three different work packages (WPs).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching HAKA-trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.",[29,133],[218,219,220,221,222,223,224,225,226],"Aftercare","Arthroplasty","Focus Groups","Hip","Interview [Publication Type]","Knee","Osteoarthritis","Patient Acceptance of Health Care","Qualitative Research","2025-06-26",{"date":229,"type":40},"2025-06-27",{"date":231,"type":21},"2026-09-01",{"date":233,"type":21},"2028-06-01",{"name":235,"class":47},"Tergooi Medical Center",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":94},"100576056","digital-rehabilitation-after-hip-arthroplasty-a-randomized-controlled-trial-100576056","NCT06780319","Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial","Digihip","Inclusion Criteria:\n\n* Have an email address and a smartphone\n* Patient speaking and writing French\n* Patient covered by a social security scheme\n\nExclusion Criteria:\n\n* Hip revision surgery, significant comorbidities (Parkinson's disease, multiple sclerosis, stroke) or psychiatric disorders (substance use) that could interfere with rehabilitation\n* Patients with disorders that make it difficult for them to express their feelings\n* Pregnant or breast-feeding patients\n* Patient under protective supervision\n* Patient not covered by a social security scheme",{"count":20,"type":21},[24],"The study aims to compare the effectiveness of tele-rehabilitation versus no physical therapy after total hip arthroplasty (THA) in improving patient-reported outcomes and functional recovery. THR is a common surgical procedure to relieve pain and improve function in patients with a variety of hip conditions. Traditional physical therapy is a standard component of the post-operative care pathway for PTH patients, but can be hampered by logistical obstacles. Tele-rehabilitation is emerging as a promising alternative, offering the potential to overcome these barriers and improve access to care. The study uses a prospective monocentric design with two arms and a follow-up time of 6 months. The primary objective is assessed using the Timed up and go Test (TUG), while secondary objectives include patient-reported outcome measures, patient satisfaction, healthcare utilization, and return to physical activity.",[29],"2025-06-10",{"date":249,"type":40},"2025-06-11",{"date":251,"type":40},"2025-06-04",{"date":253,"type":21},"2026-10-31",{"name":255,"class":47},"Clinique du Sport, Bordeaux Mérignac",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":94},"100577870","analysis-of-biomechanical-parameters-and-return-to-sport-after-total-hip-replacement-100577870","NCT06803914","Analysis of Biomechanical Parameters and Return to Sport After Total Hip Replacement","Inclusion Criteria:\n\n* Patient scheduled for total hip replacement surgery\n* Active patient with low to high level of physical activity prior to surgery\n* Informed consent\n* Complete medical file\n\nExclusion Criteria:\n\n* Contralateral hip surgery\n* Neurological disorder affecting movement (e.g. Parkinson's disease, stroke)\n* Spinal pathology affecting movement or posture\n* Dementia or inability to complete questionnaires and assessments\n* Pregnant or breast-feeding patient\n* Patient under protective supervision\n* Patient not covered by a social security scheme","65 Years",{"count":264,"type":21},50,"This prospective study aims to evaluate the dynamic biomechanical parameters of gait in active patients who have undergone total hip replacement (THR), focusing on movements critical for return to sport.",[29],{"date":249,"type":40},{"date":269,"type":40},"2025-01-30",{"date":271,"type":21},"2027-01-31",{"name":255,"class":47},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100563065","phase-3-enhanced-recovery-and-abbreviated-length-of-anticoagulation-for-thromboprophylaxis-after-primary-hip-arthroplasty-100563065","NCT06611319","ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty","ENABLE-Hip","Inclusion Criteria:\n\n1. Written informed consent\n2. Age between 18 and 85 years\n3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol\n4. Baseline Timed Up and Go (TUG) test scoring \\< 20 seconds, corresponding to a good mobility status before surgery\n5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules).\n6. Pregnancy and contraception:\n\n   1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).\n   2. Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and\u002For those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban.\n\nExclusion Criteria:\n\n1. Previous DVT or PE\n2. Hip or lower limb fracture in the previous three months\n3. Major surgical procedure within the previous three months\n4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy\n5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding\n6. Obesity with body mass index (BMI) \\> 40 kg\u002Fm2 body surface area\n7. Severe renal impairment defined as estimated glomerular filtration rate \\< 30ml\u002Fmin\n8. Severe hepatic impairment defined as Child Pugh Class B or C\n9. Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions \\[e.g., diarrhea, malabsorption\\], psychiatric illness)\n10. Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment\n11. Any other medical condition representing a contraindication to discharge within 6 days after surgery\n12. Expected requirement for major surgery within a 90-day period post THA\n13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)\n14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily\n15. Previous participation in this trial\n16. Life expectancy \\< 6 months\n17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period\n18. History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP","85 Years",{"count":282,"type":21},2932,[284],"PHASE3","Surgical hip replacement (total hip arthroplasty, THA) is associated with a high risk of venous thromboembolism, but the appropriate duration of postoperative medical thromboprophylaxis (\"anticoagulation\") remains highly controversial. The international randomized controlled trial (RCT) \"ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty\" (ENABLE-Hip) will enroll patients undergoing elective THA that are eligible for early mobilization after surgery. The trial will compare a regimen of short-duration (10-day) postoperative anticoagulation (experimental group) to standard-duration (35-day) postoperative anticoagulation (control group) using the direct oral anticoagulant Rivaroxaban (brand name: Xarelto) at the recommended dose. Thus, ENABLE-Hip will be the first major RCT to directly test an overall reduction in the duration of post-THA thromboprophylaxis instead of replacing one antithrombotic drug or regimen by another. Follow-up visits after hospital discharge will be on day 35 and on day 90 after surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis, or symptomatic or fatal pulmonary embolism, within 90 days after surgery. If ENABLE-Hip will demonstrate 'non-inferiority' of the experimental intervention, its benefits will be obvious, as patients are spared many days of unnecessary (and potentially harmful in terms of bleeding risk) anticoagulation.",[29,287],"Prevention of Venous Thromboembolism",[289,290,291,170,292,293,294,295],"Thromboprophylaxis after hip surgery","Rivaroxaban","Abbreviated length of Anticoagulation","Fast-track surgery","Early mobilization","Pulmonary embolism","Deep vein thrombosis","2025-01-15",{"date":298,"type":40},"2025-01-16",{"date":300,"type":40},"2024-11-26",{"date":302,"type":21},"2027-07",{"name":304,"class":47},"Prof. Stavros Konstantinides, MD",6,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":94},"100504563","exactech-hip-systems-post-market-clinical-follow-up-pmcf-100504563","NCT05849961","Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)","TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems","Inclusion Criteria:\n\nCohort 1:\n\n* Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject is to receive an Exactech Hip System THA for any approved indication for use.\n* The hip replacement will be performed by the investigator or a surgeon sub- investigator.\n* The devices will be used according to the approved indications.\n\nCohort 2:\n\n* Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time- period (prospectively).\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject received an Exactech Hip System THA for any approved indication for use.\n* The hip replacement was performed by the investigator or a surgeon sub-investigator.\n* The devices are\u002Fwere used according to the approved indications.\n* Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:\n\nPre-Operative:\n\nDemographic Data\n\n* Gender\n* Age at surgery\n* Height\u002FWeight\n* Indication for surgery\n* Prior Injuries\u002FSurgeries on index hip\n* Comorbidities\n\nOperative:\n\n* Date of Surgery\n* Type of Surgery (Primary \u002F Revision)\n* All component product information, including catalogue reference numbers.\n* Adverse Event Information, if applicable\n\nCohort 3:\n\nNote: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study, in which case they should be part of Cohort 2.\n\n* Skeletally mature (18 years of age or older).\n* The subject is willing and able to provide written informed consent for participation in the study.\n* Subject received an Exactech Hip System THA for any approved indication for use.\n* The hip replacement was performed by the investigator or a surgeon sub-investigator.\n* The devices are\u002Fwere used according to the approved indications.\n* Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:\n\nPre-Operative:\n\nDemographic Data\n\n* Gender\n* Age at surgery\n* Height\u002FWeight\n* Indication for surgery\n* Prior Injuries\u002FSurgeries on index hip\n* Comorbidities\n\nOperative:\n\n* Date of Surgery\n* Type of Surgery (Primary \u002F Revision)\n* All component product information, including catalogue reference numbers.\n* Adverse Event Information, if applicable\n\nExclusion Criteria:\n\n* Patient was \\\u003C18 years of age at time of surgery\n* Patient does not meet the indicated population for use criteria for this device.\n* Patient is pregnant\n* Patient is a prisoner\n* Patient has a physical or mental condition that would invalidate the results\n* Patient is contraindicated for the surgery (e.g., metal allergy)",{"count":314,"type":21},2946,"A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems",[29],"2024-06-17",{"date":319,"type":40},"2024-06-18",{"date":321,"type":40},"2023-10-13",{"date":323,"type":21},"2036-12-31",{"name":325,"class":326},"Exactech","INDUSTRY"]