[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659137":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":54,"overallOfficials":40,"centralContacts":60,"locations":69,"responsibleParty":85,"collaborators":40,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":40,"enrollmentInfo":96,"targetDuration":40,"studyType":99,"phases":100,"briefSummary":101,"conditions":102,"keywords":40,"overallStatus":71,"whyStopped":40,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Luzerner Kantonsspital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":40},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Change in volar\u002Fdorsal tilt","Volar or dorsal tilt of the distal radius (degrees), measured on the lateral wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees.","Before traction (0 minutes) and after 1, 5 and 10 minutes of tracti",{"measure":14,"description":15,"timeFrame":16},"Change in radial inclination","Radial inclination (degrees), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees.","Before traction (0 minutes) and after 1, 5 and 10 minutes of traction",{"measure":18,"description":19,"timeFrame":16},"Change in radial height","Radial height (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm.",{"measure":21,"description":22,"timeFrame":16},"Change in ulnar variance","Ulnar variance (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm.",[24,28,31,34,37],{"measure":25,"description":26,"timeFrame":27},"Proportion of fractures with acceptable radiological alignment","Percentage of participants whose fracture meets acceptable alignment criteria for volar\u002Fdorsal tilt, radial inclination, radial height and ulnar variance at each traction time point.","After 1, 5 and 10 minutes of traction",{"measure":29,"description":30,"timeFrame":16},"Time point of maximal radiological realignment","The traction time point (1, 5 or 10 minutes) at which each of the four radiological parameters (volar\u002Fdorsal tilt, radial inclination, radial height, ulnar variance) reaches its maximal correction relative to baseline.",{"measure":32,"description":33,"timeFrame":16},"Effect of fracture morphology on change in radiological alignment","Association between fracture type (AO\u002FOTA 23-A, 23-B, 23-C) and baseline displacement, and the change in the four radiological parameters over time. This is analysed with linear mixed-effects models.",{"measure":35,"description":36,"timeFrame":16},"Effect of age and sex on change in radiological alignment","Association between patient age and sex and the change in the four radiological parameters over time. This includes a sex × time interaction, analysed with linear mixed-effects models.",{"measure":38,"description":39,"timeFrame":16},"Effect of BMI, forearm circumference, time to presentation and pain on change in radiological alignment","Association between BMI, forearm circumference (a proxy for muscle volume), time from injury to emergency department presentation and maximum pain during traction, and the change in volar\u002Fdorsal tilt, radial inclination, radial height and ulnar variance over time. Pain is scored on a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). This is analysed with linear mixed-effects models.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Sequential traction (1, 5 and 10 minutes)","EXPERIMENTAL","Adults with an acute displaced distal radius fracture receive standard longitudinal mechanical traction, using finger traps on the thumb, index and middle fingers and a 5 kg counterweight. Standard wrist radiographs (PA and lateral) are taken before traction (T0) and after 10 minutes (T3). Two additional study radiographs (PA and lateral) are taken after 1 minute (T1) and 5 minutes (T2) of traction. Each participant serves as their own control. Closed reduction and casting then follow standard care.",[53],"Procedure: Longitudinal mechanical traction",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":40},"PROCEDURE","Longitudinal mechanical traction","Continuous longitudinal traction with standardized finger traps and a 5 kg weight over a pulley on the emergency department reduction frame, lasting 10 minutes. Wrist radiographs are taken at 1, 5 and 10 minutes of traction.",[49],[61,66],{"name":62,"role":63,"phone":64,"phoneExt":40,"email":65},"Jill I de Bode","CONTACT","+410412054770","jilliris.debode@luks.ch",{"name":67,"role":63,"phone":40,"phoneExt":40,"email":68},"Bryan JM van de Wall","bryan.vandewall@luks.ch",[70],{"facility":5,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Lucerne","Canton of Lucerne","6000","Switzerland","CH",{"type":78,"coordinates":79},"Point",[80,81],8.30635,47.05048,{"lat":81,"lon":80},[84],{"name":67,"role":63,"phone":64,"phoneExt":40,"email":68},{"type":86,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100659137","optimal-duration-of-longitudinal-mechanical-traction-in-displaced-radius-fractures-a-prospective-non-inferiority-study-100659137",false,"NCT07861763","Optimal Duration of Longitudinal Mechanical Traction in Displaced Radius Fractures: a Prospective Non-inferiority Study","DRF-LUKS","Inclusion Criteria:\n\nAge 18 years or older Acute, displaced distal radius fracture (AO\u002FOTA 23-A, 23-B or 23-C) presenting to the Emergency Department and requiring closed reduction with mechanical traction and cast immobilisation Written informed consent\n\nExclusion Criteria:\n\nPathological fracture Open distal radius fracture Irreducible fracture requiring immediate operative fixation Previous surgery, previous fracture, or concomitant fracture of the same (ipsilateral) upper extremity Acute neurovascular compromise requiring immediate surgical intervention Inability to provide informed consent (e.g. severe cognitive impairment, dementia, acute substance intoxication, or a language barrier with no interpreter available) Pregnancy (screened per standard ED protocol)","ALL","18 Years",{"count":97,"type":98},36,"ESTIMATED","INTERVENTIONAL",[42],"The goal of this clinical trial is to learn if 1 minute of mechanical traction lines up a broken wrist bone as well as 5 or 10 minutes of traction in adults (18 years and older) who come to the emergency department with a displaced distal radius fracture (a broken wrist with the bone pieces out of place) that needs to be set and put in a cast. The main questions it aims to answer are:\n\nIs the bone position on X-ray after 1 minute of traction no worse than after 5 or 10 minutes? Bone position is measured as wrist tilt, radial inclination, radial height and ulnar variance.\n\nAt what point during traction does the bone reach its best position?\n\nThere is no separate comparison group. Each participant serves as their own comparison. Researchers will compare X-rays taken before traction and after 1, 5 and 10 minutes of traction in the same participant to see if longer traction improves bone alignment.\n\nParticipants will:\n\nReceive standard pain relief and have their arm placed in traction with finger loops and a 5 kg weight, as in usual care Have two extra wrist X-rays (front and side view) after 1 minute and again after 5 minutes of traction, in addition to the standard X-rays before traction and after 10 minutes Have their fracture set and a cast applied as usual. Participation ends when they leave the emergency department, and there are no extra follow-up visits.",[103],"Distal Radius Fracture","2026-10-01",{"date":106,"type":107},"2026-10-06","ACTUAL",{"date":109,"type":98},"2026-09",{"date":111,"type":98},"2026-12",{"name":5,"class":6},1]