[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354557":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":135,"collaborators":137,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":25,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Soft-tissue hamstring","ACTIVE_COMPARATOR","All patients in the study will undergo arthroscopic-assisted, single-bundle, complete transphyseal, anatomic primary ACL reconstruction at the discretion of the surgeon, considering the individual patient's age, physeal status, and anticipated years of growth remaining to skeletal maturity. Patients in this arm will undergo soft-tissue autograft reconstruction using hamstrings (i.e. semitendinosus and\u002For gracilis) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.",[13],"Procedure: Soft tissue hamstring autograft",{"label":15,"type":10,"description":16,"interventionNames":17},"Quadriceps tendon","Patients in this arm will undergo soft-tissue autograft reconstruction using all-soft-tissue quadriceps (i.e. full or partial thickness) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.",[18],"Procedure: Quadriceps tendon autograft",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Soft tissue hamstring autograft","Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Quadriceps tendon autograft","Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.",[15],[31],{"name":32,"affiliation":5,"role":33},"Darren de SA, MD, FRCSC","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","9059232126","darren.desa@medportal.ca",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Nicole Simunovic, MSc","(289) 237-3224","simunon@mcmaster.ca",[44,68,81,95,110,121],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Hamilton","Ontario","L8N3Z5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.84963,43.25011,{"lat":55,"lon":54},[58,60,61,63,66],{"name":59,"role":36,"phone":25,"phoneExt":25,"email":38},"Darren de SA, MSc",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"name":62,"role":33,"phone":25,"phoneExt":25,"email":25},"Darren de SA, MD",{"name":64,"role":65,"phone":25,"phoneExt":25,"email":25},"Olufemi R Ayeni, MD, PhD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":25,"phoneExt":25,"email":25},"Devin C Peterson, MD",{"facility":69,"status":45,"city":70,"state":47,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Children's Hospital of Eastern Ontario","Ottawa","K1H 8L1",{"type":52,"coordinates":73},[74,75],-75.69812,45.41117,{"lat":75,"lon":74},[78,80],{"name":79,"role":36,"phone":25,"phoneExt":25,"email":25},"Sasha Carsen, MD",{"name":79,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":82,"status":45,"city":83,"state":47,"zip":84,"country":49,"countryCode":50,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Women's College Hospital\u002FResearch Institute","Toronto","M5S 1B2",{"type":52,"coordinates":86},[87,88],-79.39864,43.70643,{"lat":88,"lon":87},[91,93],{"name":92,"role":36,"phone":25,"phoneExt":25,"email":25},"Ananya Pathak, MSc",{"name":94,"role":33,"phone":25,"phoneExt":25,"email":25},"Jihad Abouali, MD, FRCSC",{"facility":96,"status":45,"city":97,"state":98,"zip":99,"country":49,"countryCode":50,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":52,"coordinates":101},[102,103],-73.58781,45.50884,{"lat":103,"lon":102},[106,108],{"name":107,"role":36,"phone":25,"phoneExt":25,"email":25},"Nathalie Jourdain",{"name":109,"role":33,"phone":25,"phoneExt":25,"email":25},"Marie-Lyne Nault, MD, FRCSC",{"facility":111,"status":45,"city":97,"state":98,"zip":112,"country":49,"countryCode":50,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Shriners Hospitals for Children - Canada","H4A 0A9",{"type":52,"coordinates":114},[102,103],{"lat":103,"lon":102},[117,119],{"name":118,"role":36,"phone":25,"phoneExt":25,"email":25},"Nicolas Herrera, MSc",{"name":120,"role":33,"phone":25,"phoneExt":25,"email":25},"Justin Drager, MD, FRCSC",{"facility":122,"status":45,"city":123,"state":25,"zip":25,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Kobe University","Kobe","Japan","JP",{"type":52,"coordinates":127},[128,129],135.183,34.6913,{"lat":129,"lon":128},[132,134],{"name":133,"role":36,"phone":25,"phoneExt":25,"email":25},"Kanto Nagai, MD, PhD",{"name":133,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":136,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[138,140,142],{"name":139,"class":6},"Canadian Orthopaedic Foundation",{"name":141,"class":6},"The Physicians' Services Incorporated Foundation",{"name":143,"class":144},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100354557","soft-tissue-quadriceps-autograft-acl-reconstruction-in-the-skeletally-immature-vs-hamstrings-100354557",false,"NCT03896464","Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings","Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial","SQuASH","Inclusion Criteria\n\n1. Patients aged 10-18 years.\n2. History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.\n3. Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.\n4. X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard bone age left hand posteroanterior (PA) radiographs).\n5. Patient involved in sport (competitive and\u002For recreational level) prior to injury.\n6. Patient and parent\u002Fguardian speak, read, and understand the language of the clinical site.\n7. Patient and parent\u002Fguardian provide informed consent and\u002For assent.\n\nExclusion Criteria\n\n1. Evidence (i.e. radiographic and\u002For arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 (i.e., lesions extending down to 50% of the cartilage depth) and higher osteoarthritis that is symptomatic, requiring treatment other than debridement or microfracture.\n2. Tibial eminence\u002Fspine fractures treated surgically.\n3. Concomitant collateral, posterior cruciate, and\u002For cartilage pathology requiring surgical reconstruction and\u002For advanced restoration techniques (i.e., osteochondral allograft or autograft transfer, matrix-induced autologous chondrocyte implantation, particulate juvenile articular cartilage allograft transplantation).\n4. Previous ACL reconstruction in the affected knee or contralateral knee.\n5. Previous distal femur and\u002For proximal tibial\u002Ffibular physeal injury in the affected knee or contralateral knee.\n6. Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.\n7. Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).\n8. ACL reconstruction utilizing synthetic grafts.\n9. Primary ACL repair.\n10. Patient diagnosed with inflammatory arthropathy.\n11. Significant medical co-morbidities (requiring daily assistance for activities of daily living).\n12. Patient, parent\u002Fguardian, and\u002For clinical investigator believe the patient will have difficulty maintaining follow-up.","ALL","10 Years","18 Years",{"count":157,"type":158},352,"ESTIMATED","INTERVENTIONAL",[161],"NA","To date, the use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option. However, no Randomised Control Trial (RCT) has examined the efficacy of the quadriceps tendon autograft in primary paediatric ACL reconstruction compared to the historical \"gold-standard\" soft-tissue hamstring autograft in this population. In light of its evidence for favourable outcomes in the adult population, and the (albeit limited) evidence showing safety and promise in the paediatric population, clinical equipoise exists for assessing its impact on outcomes in paediatric patients at the index surgery. This is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.",[164],"ACL - Anterior Cruciate Ligament Rupture",[166,9,167],"Autograft","Quadriceps Tendon","2025-03-25",{"date":170,"type":171},"2025-03-30","ACTUAL",{"date":173,"type":171},"2020-01-01",{"date":175,"type":158},"2030-01-01",{"name":5,"class":6},6]