[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spaarne Gasthuis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":161},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,81,108,134],{"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":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100632979","poly-vs-hybrid-glenoid-in-stemless-atsa-100632979",false,"NCT07520721","Poly vs Hybrid Glenoid in Stemless aTSA","A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty","Poly vs hybrid","Inclusion Criteria:\n\n\\-\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Both genders;\n2. Age 18 years old;\n3. Life expectancy over 5 years;\n4. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;\n5. Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based on physical examination, medical history and X ray examination. (In cases where bilateral aTSA's are indicated, the patient will be included for the second aTSA again when the patient meets the inclusion criteria);\n6. Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;\n7. A diagnosis in the target shoulder of osteoarthritis; according to the classification of Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 degrees.\n8. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;\n9. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.\n\nExclusion Criteria:\n\n1. Patient requiring revision shoulder arthroplasty;\n2. Osteoporosis with a history of non-traumatic fractures;\n3. Steroid injections within the previous 6 months;\n4. Contralateral shoulder replacement within the previous 3 months;\n5. Meta-epiphyseal bony defect (including large cysts);\n6. Significant proven or suspicious infection of the target shoulder or any serious infectious disease\n7. Significant neurological or musculoskeletal disorders that may compromise functional recovery;\n8. Known or suspicious hypersensitivity to the metal or other materials of the implant;\n9. Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;\n10. Any systemic disease which may affect outcome.\n11. Active or metastatic neoplastic disease\n12. Chemotherapy and\u002For radiotherapy within the last 6 months\n13. Previous organ transplant\n14. Participation in any clinical research study that may interfere with this study\n15. A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.\n16. Current substance use disorder (excluding nicotine\u002Ftabacco use disorder) or moderate or severe alcohol use disorder.\n17. Imminent suicide risk.\n18. Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment","ALL","18 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"NA","Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.",[27],"Glenohumeral Osteoarthritis",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Osteoarthritis","Shoulder Joint","Arthroplasty, Replacement, Shoulder","Shoulder Prosthesis","Prostheses and Implants","Prosthesis Fixation","Prosthesis Failure","Prosthesis Loosening","Bone Cements","Polyethylene","Titanium","Osseointegration","Radiography","RECRUITING","2026-04-02",{"date":45,"type":46},"2026-04-09","ACTUAL",{"date":48,"type":46},"2025-06-30",{"date":50,"type":21},"2036-12",{"name":52,"class":53},"Spaarne Gasthuis","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100580723","phase-3-laparoscopic-antibiotic-lavage-to-prevent-intra-abdominal-abscess-formation-in-complicated-appendicitis-100580723","NCT06841003","Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis","Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis (ALPACA), a Multicenter Single-blinded RCT.","ALPACA","Inclusion Criteria:\n\n* All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of CA undergoing a laparoscopic appendectomy for intra-operative confirmed CA that can provide a signed written consent form.\n\nExclusion Criteria:\n\n* Age under 8 years;\n* Not able to give informed consent (language barrier, legally incapable)\n* Any contraindication for the use of the study medication:\n\n  * Hypersensitivity to clindamycin or to any of the excipients benzyl alcohol, sodium edetate, water, or to lincomycin;\n  * Hypersensitivity to gentamicin or to sodium metabisulfite: particularly in asthmatic patients, this may trigger bronchospasms and anaphylactic shock or to any of the excipients: disodium edetate, sodium hydroxide, sodium metabisulfite (E223), water for injections;\n* Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection:\n\n  * Sepsis-induced hypotension\n  * Lactate above upper limits laboratory normal\n  * Urine output \\\u003C0.5 mL\u002Fkg\u002Fh for more than 2h despite adequate fluid resuscitation\n  * Acute lung injury with PaO2\u002FFiO2 \\\u003C250 in the absence of pneumonia as infection source\n  * Acute lung injury with PaO2\u002FFiO2 \\\u003C200 in the presence of pneumonia as infection source\n  * Creatinine \\>2.0 mg\u002FdL (176.8 μmol\u002FL)\n  * Bilirubin \\>2mg\u002FdL (34.2 μmol\u002FL)\n  * Platelet count \\\u003C 100,000 μL\n  * Coagulopathy (international normalized ratio (INR) \\> 1.5);\n* ASA IV score;\n* Known malignancy;\n* Renal dysfunction (i.e. eGFR ≤ 60);\n* Immunocompromised patients (i.e. hematological malignancies, HIV\u002FAIDS, bone marrow transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, chemotherapy, dialysis, solid organ transplant, and immunosuppressant use (such as corticosteroids in patients with rheumatoid arthritis));\n* Pregnancy;\n* Known allergies to either gentamicin or clindamycin;\n* Known colonization of bacteria resistant to either gentamicin or clindamycin;","8 Years",{"count":65,"type":21},752,[67],"PHASE3","Appendicitis is one of the most common causes of acute surgical admission. Presently, two types of appendicitis are distinguished: complicated and uncomplicated (phlegmonous). Complicated appendicitis (CA) is defined as gangrenous and\u002For perforated appendicitis and\u002For appendicitis with an intra-abdominal or pelvic abscess. Laparoscopic appendectomy has become the preferential mode of surgical treatment. However, development of an intra-abdominal abscess (IAA) remains an important and clinically relevant complication following appendectomy, especially in complicated appendicitis. Although patients with complicated appendicitis receive postoperative intravenous antibiotics, the incidence of IAA remains considerable. The reported incidence of IAA in children and adults with CA is 7.9% - 24%. We recently reported an IAA rate of 12.3% after laparoscopic appendectomy for CA in our own institution. Patients with IAA are readmitted and treated with either antibiotics, image-guided percutaneous drainage, surgical reintervention, or a combination of these treatments. Furthermore, IAA represents a considerable burden for the healthcare system with high readmission rates and reinterventions, prolonged hospital stay, and therefore increased medical costs. Intra operative techniques aiming at more effective infection source control represent a clinically relevant area of investigation. Laparoscopic antibiotic lavage represents a promising concept in order to reduce intra-abdominal abscess formation. Antibiotic lavage is mainly known for the treatment of peritoneal dialysis associated peritonitis. Several studies show promising results of antibiotic peritoneal lavage on the incidence of surgical site infections (SSIs) including IAA in patients with CA. However, these studies were retrospective or conducted in a small number of patients who underwent an open appendectomy while high quality randomized controlled trials have not been performed yet.\n\nThe aim of the ALPACA study is to evaluate the effect of laparoscopic antibiotic peritoneal lavage with gentamicin \u002F clindamycin for 3 minutes after appendectomy on the incidence of IAA in patients with CA.",[70,71],"Complicated Appendicitis","Intra-Abdominal Abscess","NOT_YET_RECRUITING","2025-02-18",{"date":75,"type":46},"2025-02-21",{"date":77,"type":21},"2025-02",{"date":79,"type":21},"2027-05",{"name":52,"class":53},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":54},"100510475","musical-intervention-during-iv-line-placement-in-neonates-100510475","NCT05926921","Musical Intervention During IV-line Placement in Neonates","'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'","Inclusion Criteria:\n\n* connected to a monitor that records vital signs\n* receives an IV-line\n\nExclusion Criteria:\n\n* has hearing impairment",{"count":89,"type":21},50,[24],"The goal of this clinical trial is to test the effect of music in reducing the pain felt by newborn children during an intravenous line procedure. An intravenous line is a small tube brought into a vein by using a needle. The main questions it aims to answer are:\n\n1. Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music?\n2. How do parents and medical staff experience the music that's being played? Participants will all receive the same care and treatments as usual. The only difference being about half of the participants will be randomly assigned to the group that gets music.\n\nResearchers will compare the music group to the non-music group to see if there is any difference in vital signs and behaviors of the child.",[93],"Pain",[95,96,97,98,99],"intravenous line","newborn","music","pain management","musical therapy","2024-06-12",{"date":102,"type":46},"2024-06-13",{"date":104,"type":46},"2023-06-19",{"date":106,"type":21},"2024-10-09",{"name":52,"class":53},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100528166","multifactorial-approach-training-for-anterior-shoulder-instability-in-patients-undergoing-arthroscopic-bankart-repair-100528166","NCT06157229","Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair","Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial","MATASI","Inclusion Criteria:\n\n* Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)\n* Aged between 18-67 years\n* Planned arthroscopic Bankart repair (ABR) surgery\n* Understanding of spoken and written Dutch language\n* Written informed consent (according to the ICH-GCP guidelines)\n* Positive apprehension sign at physical examination\n\nExclusion Criteria:\n\n* Posterior or multidirectional shoulder instability\n* Presence of hyperlaxity of the upper extremity and absence of sulcus sign and \\>85 degrees of external rotation with the arm at the side at physical examination\n* Connective tissue disorders (e.g. Ehlers-Danlos)\n* Aged \\\u003C18 or \\>67 years\n* Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)\n* History of soft tissue repair or bone block procedure on one of both shoulders\n* Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)\n* Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)\n* Neurological disorders or systemic disease\n* Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder\n* Hill-Sachs lesion visible on external rotation radiographs\n* Greater tubercle fracture","67 Years",{"count":118,"type":21},100,[24],"This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation, following the American Society of Shoulder and Elbow Therapists guideline and patients that underwent 'multifactorial approach training', which focusses on decreasing kinesiophobia and fear of recurrent dislocations.\n\nThe study population comprises patients who will undergo Arthroscopic Bankart Repair (ABR) after a traumatic anterior shoulder dislocation at Spaarne Gasthuis Haarlem\u002FHoofddorp, OLVG Amsterdam, Amstelland Ziekenhuis Amstelveen, Gelre Ziekenhuizen, Medisch Spectrum Twente, or Flevoziekenhuis Almere.",[122,123,124,125],"Shoulder Instability","Shoulder Dislocation or Subluxation","Fear of Movement","Kinesiophobia","2023-11-27",{"date":128,"type":46},"2023-12-05",{"date":130,"type":21},"2024-01-01",{"date":132,"type":21},"2027-06-01",{"name":52,"class":53},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":54},"100381520","the-attune-knee-outcome-study-100381520","NCT04247672","The ATtune Knee Outcome Study","The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty","ATKOS","Inclusion Criteria:\n\n* End-stage osteoarthritis of the knee warranting joint replacement therapy.\n* Indicated for an ATTUNE total knee system as part of regular clinical practice.\n* Capability and willingness to sign informed consent and comply with follow-up procedures.\n* Capable enough in Dutch or English to be able to understand study procedures\n\nExclusion Criteria:\n\n* Unable or unwilling to sign informed consent and comply with follow-up\n* Indication for primary revision arthroplasty\n* Absolute indication for cemented fixation (decreased bone stock\u002Fquality of spongiosa)","21 Years","90 Years",{"count":145,"type":21},900,"OBSERVATIONAL","To accomodate dissatisfied patients with a total knee arthroplasty (TKA) and improve outcomes, several knee systems have been developed. The cemented ATTUNE TKA shows superiority over other established knee systems at short-term, abating with longer follow-up. There have been no studies reporting on the results of the uncemented version of the ATTUNE. Therefore, the main objective of the current study was to report patient reported outcome measures (PROMs), survivorship and complications associated with the uncemented ATTUNE TKA.",[149,150,151,152],"Osteoarthritis, Knee","Knee Osteoarthritis","Knee Rheumatism","Rheumatoid Arthritis","2022-04-26",{"date":155,"type":46},"2022-04-27",{"date":157,"type":46},"2020-02-03",{"date":159,"type":21},"2036-01-22",{"name":52,"class":53},""]