[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483403":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":25,"id":60,"slug":25,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arthroscopic assisted Cancellous chips graft reconstruction","EXPERIMENTAL","The arthroscopic technique is potentially less invasive with minimal donor site morbidity and potentially faster time to union because of minimal trauma to the ligament structures, joint capsule, and the tenuous blood supply. It may also have advantageous osteogenic properties compared to a structural graft.\n\nCurrently, studies have reported similar union rates, patient reported outcomes score, and functional score compared to open graft technique. Results in patients with gross deformity are debated with some studies favoring conventional open structural graft and other found no difference in outcome between the techniques.",[13],"Procedure: Graft reconstruction and internal fixation with compression screw",{"label":15,"type":16,"description":17,"interventionNames":18},"Open cancellous graft reconstruction","ACTIVE_COMPARATOR","Convention open technique with debridement of the nonunion side, insertion of cancellous graft from the iliac crest and osteosynthesis with compression screw is currently commonly applied in scaphoid nonunion.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Graft reconstruction and internal fixation with compression screw","Patients suffering from scaphoid nonunion are treated surgically by debridement, graft reconstruction and internal fixation with compression screw",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Robert Gvozdenoviz, MD","Orthopedic department, Copenhagen university hospital Gentofte Hospital","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Morten Kjaer, MD","CONTACT","+45 38672111","morten.kjaer.02@regionh.dk",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Camilla Stokkebro, Secretary","+45 38673280","camilla.stokkebro@regionh.dk",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University Hospital Herlev\u002FGentofte, Department of Orthopedic Surgery, Clinic for Shoulder-, Elbow- and Hand Surgery, Hellerup, Denmark","RECRUITING","Hellerup","2900","Denmark",{"type":49,"coordinates":50},"Point",[51,52],12.57093,55.73204,{"lat":52,"lon":51},[55],{"name":33,"role":34,"phone":56,"phoneExt":25,"email":36},"004538672111",{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Morten Kjaer","Medical doctor, PhD student","100483403",false,"NCT05574582","Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed\u002FNonunion","Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed\u002FNon-union in Adults: Study Protocol for a Randomized Clinical Trial","Inclusion Criteria:\n\n1. Patients aged 18-68 years.\n2. A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \\>1mm or comminution and failed non-operative treatment.\n3. Scaphoid fracture without healing \\>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.\n4. ASA 1-3.\n\nExclusion Criteria:\n\n1. Open fractures\n2. Associated trans-scaphoid perilunate dislocation.\n3. Associated fracture in the hand\u002Fupper extremity.\n4. Previous failed surgical treatment for scaphoid delayed\u002Fnon-union.\n5. Stage 2 SNAC or above.\n6. Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.\n7. Patients with gross humpback deformity of HLR \\>0.75 and\u002For DCA \\\u003C70⁰.\n8. Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.","ALL","18 Years","68 Years",{"count":70,"type":71},88,"ESTIMATED","INTERVENTIONAL",[74],"NA","Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed\u002Fnon-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed\u002Fnonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand\u002Fupper extremity, previous failed surgical treatment for scaphoid delayed\u002Fnonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity.\n\nPatients are stratified for smoking habits, proximal pole involvement, and displacement of \\>\u002F\\\u003C2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.",[77,78],"Scaphoid Fracture","Scaphoid Nonunion",[80,81,82,83,84,85],"Scaphoid","Scaphoid nonunion","Cancellous","Graft","Arthroscopic","Timo to union","2023-02-28",{"date":88,"type":89},"2023-03-01","ACTUAL",{"date":91,"type":89},"2023-02-15",{"date":93,"type":71},"2028-01-01",{"name":5,"class":6},1]