[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658123":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":50,"studyPopulation":41,"armGroups":51,"interventions":63,"overallOfficials":69,"centralContacts":73,"locations":82,"responsibleParty":97,"collaborators":41,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":41,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":41,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":123,"overallStatus":134,"whyStopped":41,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Acetabular Index at 24 Months of Age","Acetabular index, measured in degrees using the lateral-edge method on a standardised anteroposterior pelvic radiograph, will be assessed for the prespecified index hip. Two independent assessors blinded to treatment allocation will measure each radiograph, and the mean of their measurements will be used for analysis. The mean acetabular index will be compared between the 8-week and 12-week Pavlik harness treatment groups. The non-inferiority margin is 2°.","At 24 months of age, with an allowable assessment window of ±3 months.",[14,18,21,24,27,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Caregiver-Reported Experience Measured Using the EMBRACE Tool","Caregiver-reported experience with Pavlik harness treatment will be assessed using the Evaluation Measure for BRACe Experience (EMBRACE), a DDH-specific questionnaire. An overall EMBRACE score will be calculated according to the instrument's prespecified scoring method. Scores range from 8 to 40, with higher scores indicating a better experience.","At 2 weeks after randomisation and at harness discontinuation, occurring at 8 or 12 weeks after randomisation or following protocol-defined extension, up to 20 weeks after randomisation.",{"measure":19,"description":20,"timeFrame":17},"Caregiver Reported Impact of Harness Treatment on the Infant Using VAS Item","The caregiver will rate the perceived impact of Pavlik harness treatment on the infant using a 0-10 visual analogue scale. A score of 0 indicates low child discomfort\u002Fdistress and a score of 10 indicates high child discomfort\u002Fdistress.",{"measure":22,"description":23,"timeFrame":17},"Caregiver Reported Impact of Harness Treatment on the Caregiver Using VAS Item","The caregiver will rate the perceived impact of Pavlik harness treatment on themselves using a 0-10 visual analogue scale. A score of 0 indicates low burden and a score of 10 indicates high burden.",{"measure":25,"description":26,"timeFrame":17},"Caregiver Reported Impact of Harness Treatment on the Family Using VAS Item","The caregiver will rate the perceived impact of Pavlik harness treatment on the family using a 0-10 visual analogue scale. A score of 0 indicates low family burden and a score of 10 indicates high family burden.",{"measure":28,"description":29,"timeFrame":17},"Caregiver Reported Satisfaction with DDH Care Using VAS Item","The caregiver will rate their satisfaction with DDH care using a 0-10 visual analogue scale. A score of 0 indicates low satisfaction and a score of 10 indicates high satisfaction.",{"measure":31,"description":32,"timeFrame":33},"Failure to Meet Protocol-Defined Stopping Criteria at 8 Weeks","Among participants assigned to the 8-week strategy, the proportion who do not meet all protocol-defined stopping criteria at the 8-week assessment will be reported. Failure is defined as one or more treated hips having an alpha angle \\\u003C60°, femoral head coverage \\\u003C50%, or absence of a stable, concentric reduction on dynamic ultrasound. Associations between failure and prespecified baseline clinical and sonographic factors will be explored.","At 8 weeks after randomisation.",{"measure":35,"description":36,"timeFrame":37},"Healthcare Resource Utilization","Healthcare resource utilization will be assessed as the cumulative number of clinic visits, ultrasound examinations, and unscheduled DDH-related clinical contacts occurring during the study period. Resource use will be compared between the 8-week and 12-week Pavlik harness treatment groups.","From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).",{"measure":39,"description":40,"timeFrame":37},"Treatment-Related Complications","Treatment-related complications will include skin complications requiring treatment modification, femoral nerve palsy, proximal femoral growth disturbance, and loss of hip centring requiring a change in treatment. Subsequent interventions, including additional brace treatment outside protocol-defined extensions or operative treatment, will also be recorded. The number and proportion of participants experiencing each event will be reported by treatment group.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":48},"SINGLE",[49],"OUTCOMES_ASSESSOR","Single-centre, parallel-group, non-inferiority randomised controlled trial comparing two durations of Pavlik harness treatment (8 weeks versus the current 12-week standard) for infants ≤6 months with developmental dysplasia of the hip (DDH). Participants are randomised 1:1 after sonographic hip centring (or at brace initiation for centred dysplastic hips), with allocation stratified by key clinical factors. The primary hypothesis is that 8 weeks of post-centring wear is non-inferior to 12 weeks in terms of acetabular development at 2 years, while potentially improving caregiver experience and health-care efficiency.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"8-Week Arm","EXPERIMENTAL","Participants randomised to this group will undergo an 8-week post-centring Pavlik harness maturation period. If predefined stopping criteria are not met at 8 weeks, treatment will be extended according to the study protocol. Clinical and imaging assessments will be completed according to the established care pathway.",[57],"Device: Pavlik Harness",{"label":59,"type":60,"description":61,"interventionNames":62},"12-Week Arm","ACTIVE_COMPARATOR","Participants randomised to this group will undergo the SickKids standard 12-week post-centring Pavlik harness maturation period. If predefined stopping criteria are not met at 12 weeks, treatment will be extended according to the study protocol. Clinical and imaging assessments will be completed according to the established care pathway.",[57],[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":41},"DEVICE","Pavlik Harness","The intervention is the duration of Pavlik harness use after sonographic centring. The Pavlik harness itself is unchanged: a commercially available soft brace positioning the hips in flexion and abduction to maintain reduction. No modifications are introduced to fitting technique, wear schedule, caregiver education, skin checks, or monitoring. All care follows the existing SickKids protocol used in routine practice. The harness is worn full time (24 hours\u002Fday initially), with allowance for up to 1 hour\u002Fday removal for hygiene after 5 weeks of treatment.",[59,53],[70],{"name":71,"affiliation":5,"role":72},"Luckshman Bavan","PRINCIPAL_INVESTIGATOR",[74,79],{"name":71,"role":75,"phone":76,"phoneExt":77,"email":78},"CONTACT","416-813-7654","415513","luckshman.bavan@sickkids.ca",{"name":80,"role":75,"phone":41,"phoneExt":41,"email":81},"Olivia Garisto","olivia.garisto@sickkids.ca",[83],{"facility":5,"status":41,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Toronto","Ontario","M5G 1X8","Canada","CA",{"type":90,"coordinates":91},"Point",[92,93],-79.39864,43.70643,{"lat":93,"lon":92},[96],{"name":71,"role":75,"phone":76,"phoneExt":77,"email":78},{"type":72,"investigatorFullName":71,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Staff Orthopaedic Surgeon, Division of Orthopaedic Surgery, The Hospital for Sick Children","100658123","8-vs-12-weeks-a-pavlik-harness-trial-100658123",false,"NCT07847619","8 vs 12 Weeks: A Pavlik Harness Trial","Optimising Post-Centring Pavlik Time in Infant DDH: A Non-Inferiority RCT of 8 vs 12 Weeks","Inclusion Criteria:\n\n* Age: \\\u003C= 6 months of chronological age at time the maturation period is initiated (hip centred).\n* Diagnosis of DDH confirmed on standardised coronal hip ultrasound per institutional protocol, with measurement of α angle and femoral head coverage, meeting one of two entry phenotypes:\n* Decentred hip at presentation (subluxated\u002Fdislocated, femoral head coverage \\\u003C 40%)\n* Centred dysplastic hip at presentation (femoral head coverage ≥ 40%, α \\\u003C 60°)\n* Treatment plan: Deemed suitable for Pavlik harness as per institutional guidelines.\n\nExclusion Criteria:\n\n* Previous treatment: Prior use of Pavlik harness, alternative brace, or surgical intervention for DDH. (Clarification: for infants presenting with decentred hips, enrolment is only after sonographic centring; the pre-enrolment harnessing used to achieve centring does not constitute prior treatment, and does not preclude participation)\n* Decentred hips failing to centre by 3 weeks in harness, requiring transition to fixed abduction brace or surgical reduction.\n* Secondary non-idiopathic dysplasia: Known neuromuscular disorders, connective tissue disorders, or genetic syndromes (e.g. spina bifida, arthrogryposis, Ehlers-Danlos syndrome).\n* Prematurity: Infants born at \\\u003C34 weeks gestational age.\n* Medical contraindications to safe Pavlik use or study procedures.\n* Concurrent research participation: Enrolment in another interventional clinical trial that may confound outcomes.","ALL","0 Months","6 Months",{"count":110,"type":111},110,"ESTIMATED","INTERVENTIONAL",[114],"NA","Developmental dysplasia of the hip is the most common bone and joint condition in babies. It is usually treated with a harness that holds the hips in a safe position so they can develop normally. After the hip is confirmed to be in the correct position, babies are commonly kept in the harness for up to 12 weeks or more. While effective, wearing a harness for this length of time can be challenging for families. It can make everyday care such as feeding, bathing and dressing more difficult, and add stress during an important time for bonding.\n\nThis trial compares two treatment options: 8 versus 12 weeks of harness wear. The 8-week option is being tested because research has shown that most hips appear normal on ultrasound by this point. The main measure of success is whether the hip looks normal on x-ray two years after treatment. Families will also be asked about their experience and treatment-related problems.\n\nIf the shorter option is as effective as the longer option, many babies could spend less time in brace, reducing burden without compromising outcomes. Because this trial is embedded in routine care, results can be put into practice quickly and guide care for babies across Ontario and beyond.",[117,118,119,120,121,122],"Developmental Dysplasia of Hip","DDH","Developmental Dysplasia of the Hip","Developmental Dysplasia of the Hip (DDH)","Hip Dysplasia, Developmental","Hip Dysplasia, Congenital, Nonsyndromic",[66,124,125,126,127,128,129,130,131,132,133],"Pavlik","Brace Treatment","Hip dysplasia","Infant","Paediatric Orthopaedics","Harness treatment","treatment duration","8 weeks","12 weeks","developmental dysplasia of the hip","NOT_YET_RECRUITING","2026-09-23",{"date":137,"type":138},"2026-09-29","ACTUAL",{"date":140,"type":111},"2027-01",{"date":142,"type":111},"2030-03",{"name":5,"class":6},1]