An interventional study of Pavlik Harness in Developmental Dysplasia of Hip, DDH and Developmental Dysplasia of the Hip, sponsored by The Hospital for Sick Children. Not yet recruiting at 1 site in Canada. Open to participants aged 0 Months to 6 Months. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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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.
This 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.
If 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.
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.
57 studies on the registry are indexed under Hip Dislocation, Congenital; 7 are open to participants now.
This study's planned enrollment of 110 is close to the median of 116 across 38 interventional studies indexed under Hip Dislocation, Congenital.
Browse Hip Dislocation, Congenital studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Hip Dislocation, Congenital, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hip Dislocation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pavlik Harness
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.
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/day initially), with allowance for up to 1 hour/day removal for hygiene after 5 weeks of treatment.
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°.
Time frame: At 24 months of age, with an allowable assessment window of ±3 months.
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.
Time frame: 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.
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/distress and a score of 10 indicates high child discomfort/distress.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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 \<60°, femoral head coverage \<50%, or absence of a stable, concentric reduction on dynamic ultrasound. Associations between failure and prespecified baseline clinical and sonographic factors will be explored.
Time frame: At 8 weeks after randomisation.
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.
Time frame: From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).
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.
Time frame: From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).
Plan to share: No — There is currently no plan to share individual participant data (IPD) from this trial. Study data will be stored securely at The Hospital for Sick Children in accordance with institutional policies and applicable privacy requirements.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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