Developmental Dysplasia of HipNCT07847619
8 vs 12 Weeks: A Pavlik Harness Trial
A study testing Pavlik Harness in people with Developmental Dysplasia of Hip and DDH, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Developmental Dysplasia of Hip, DDH, Developmental Dysplasia of the Hip
- What is being tested?
- Pavlik Harness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: <= 6 months of chronological age at time the maturation period is initiated (hip centred).
- 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:
- Decentred hip at presentation (subluxated/dislocated, femoral head coverage < 40%)
- Centred dysplastic hip at presentation (femoral head coverage ≥ 40%, α < 60°)
- Treatment plan: Deemed suitable for Pavlik harness as per institutional guidelines.
Who cannot join
- 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)
- Decentred hips failing to centre by 3 weeks in harness, requiring transition to fixed abduction brace or surgical reduction.
- Secondary non-idiopathic dysplasia: Known neuromuscular disorders, connective tissue disorders, or genetic syndromes (e.g. spina bifida, arthrogryposis, Ehlers-Danlos syndrome).
- Prematurity: Infants born at <34 weeks gestational age.
- Medical contraindications to safe Pavlik use or study procedures.
- Concurrent research participation: Enrolment in another interventional clinical trial that may confound outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia Garisto contact
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Luckshman Bavan, 416-813-7654 ext. 415513, luckshman.bavan@sickkids.ca
About this study
Official title: Optimising Post-Centring Pavlik Time in Infant DDH: A Non-Inferiority RCT of 8 vs 12 Weeks
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.
Read the detailed description
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.
- Conditions
- Developmental Dysplasia of Hip, DDH, Developmental Dysplasia of the Hip, Developmental Dysplasia of the Hip (DDH), Hip Dysplasia, Developmental, Hip Dysplasia, Congenital, Nonsyndromic
- Being tested
- Pavlik Harness
- Keywords
- Pavlik Harness, Pavlik, Brace Treatment, Hip dysplasia, Infant, Paediatric Orthopaedics, Harness treatment, treatment duration, 8 weeks, 12 weeks, developmental dysplasia of the hip
- Medical subject headings
- Hip Dislocation, Developmental Dysplasia of the Hip, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pavlik HarnessDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pavlik Harness |
| 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. Receives: Device: Pavlik Harness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°.
Measured: At 24 months of age, with an allowable assessment window of ±3 months.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luckshman Bavan, The Hospital for Sick Children
- Investigators
- Luckshman Bavan, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847619
- Sponsor's protocol ID
- 4266
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Behman AL, Bradley CS, Maddock CL, Sharma S, Kelley SP. Testing of an Ultrasound-Limited Imaging Protocol for Pavlik harness Supervision (TULIPPS) in developmental dysplasia of the hip: a randomized controlled trial. Bone Joint J. 2022 Sep;104-B(9):1081-1088. doi: 10.1302/0301-620X.104B9.BJJ-2022-0350.R2.
PubMed 36047018Upasani VV, Bomar JD, Fitzgerald RE, Schupper AJ, Kelley SP; International Hip Dysplasia Registry. Prolonged Brace Treatment Does Not Result in Improved Acetabular Indices in Infantile Dislocated Hips. J Pediatr Orthop. 2022 May-Jun 01;42(5):e409-e413. doi: 10.1097/BPO.0000000000002110.
PubMed 35200217Kelley SP, Feeney MM, Maddock CL, Murnaghan ML, Bradley CS. Expert-Based Consensus on the Principles of Pavlik Harness Management of Developmental Dysplasia of the Hip. JB JS Open Access. 2019 Oct 7;4(4):e0054. doi: 10.2106/JBJS.OA.18.00054. eCollection 2019 Oct-Dec.
PubMed 32043064Bradley CS, Verma Y, Maddock CL, Wedge JH, Gargan MF, Kelley SP. A comprehensive nonoperative treatment protocol for developmental dysplasia of the hip in infants : a prospective longitudinal cohort study. Bone Joint J. 2023 Aug 1;105-B(8):935-942. doi: 10.1302/0301-620X.105B8.BJJ-2023-0149.R1.
PubMed 37524345Bavan L, Bradley CS, Verma Y, Kelley SP. Optimizing time in harness : factors associated with sonographic resolution of developmental dysplasia of the hip during Pavlik treatment. Bone Joint J. 2025 Jan 1;107-B(1):118-123. doi: 10.1302/0301-620X.107B1.BJJ-2024-0443.R1.
PubMed 39740689
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Post-Centring Pavlik Time in Infant DDH: A Non-Inferiority RCT of 8 vs 12 Weeks
- ClinicalTrials.gov ID
- NCT07847619
- Acronym / sponsor ID
- 4266
- Conditions
- Developmental Dysplasia of Hip, DDH, Developmental Dysplasia of the Hip, Developmental Dysplasia of the Hip (DDH), Hip Dysplasia, Developmental, Hip Dysplasia, Congenital, Nonsyndromic
- Keywords
- Pavlik Harness, Pavlik, Brace Treatment, Hip dysplasia, Infant, Paediatric Orthopaedics, Harness treatment, treatment duration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-Week Arm | Experimental | Device: Pavlik HarnessParticipants 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. |
| 12-Week Arm | Active comparator | Device: Pavlik HarnessParticipants 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. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: <= 6 months of chronological age at time the maturation period is initiated (hip centred).
- 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:
- Decentred hip at presentation (subluxated/dislocated, femoral head coverage < 40%)
- Centred dysplastic hip at presentation (femoral head coverage ≥ 40%, α < 60°)
- Treatment plan: Deemed suitable for Pavlik harness as per institutional guidelines.
Key exclusion criteria (6 listed)
- 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)
- Decentred hips failing to centre by 3 weeks in harness, requiring transition to fixed abduction brace or surgical reduction.
- Secondary non-idiopathic dysplasia: Known neuromuscular disorders, connective tissue disorders, or genetic syndromes (e.g. spina bifida, arthrogryposis, Ehlers-Danlos syndrome).
- Prematurity: Infants born at <34 weeks gestational age.
- Medical contraindications to safe Pavlik use or study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pavlik HarnessThe 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. | Device | 12-Week Arm, 8-Week Arm |
Primary outcome
Acetabular Index at 24 Months of Age
Time frame: At 24 months of age, with an allowable assessment window of ±3 months.
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°.
8 secondary outcomes
Caregiver-Reported Experience Measured Using the EMBRACE Tool
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
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
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
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
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
Time frame: At 8 weeks after randomisation.
Healthcare Resource Utilization
Time frame: From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).
Treatment-Related Complications
Time frame: From randomisation through the assessment at 24 months of age (allowable assessment window of ±3 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 36047018Behman AL, Bradley CS, Maddock CL, Sharma S, Kelley SP. Testing of an Ultrasound-Limited Imaging Protocol for Pavlik harness Supervision (TULIPPS) in developmental dysplasia of the hip: a randomized controlled trial. Bone Joint J. 2022 Sep;104-B(9):1081-1088. doi: 10.1302/0301-620X.104B9.BJJ-2022-0350.R2.
- Background: PubMed 35200217Upasani VV, Bomar JD, Fitzgerald RE, Schupper AJ, Kelley SP; International Hip Dysplasia Registry. Prolonged Brace Treatment Does Not Result in Improved Acetabular Indices in Infantile Dislocated Hips. J Pediatr Orthop. 2022 May-Jun 01;42(5):e409-e413. doi: 10.1097/BPO.0000000000002110.
- Background: PubMed 32043064Kelley SP, Feeney MM, Maddock CL, Murnaghan ML, Bradley CS. Expert-Based Consensus on the Principles of Pavlik Harness Management of Developmental Dysplasia of the Hip. JB JS Open Access. 2019 Oct 7;4(4):e0054. doi: 10.2106/JBJS.OA.18.00054. eCollection 2019 Oct-Dec.
- Background: PubMed 37524345Bradley CS, Verma Y, Maddock CL, Wedge JH, Gargan MF, Kelley SP. A comprehensive nonoperative treatment protocol for developmental dysplasia of the hip in infants : a prospective longitudinal cohort study. Bone Joint J. 2023 Aug 1;105-B(8):935-942. doi: 10.1302/0301-620X.105B8.BJJ-2023-0149.R1.
- Background: PubMed 39740689Bavan L, Bradley CS, Verma Y, Kelley SP. Optimizing time in harness : factors associated with sonographic resolution of developmental dysplasia of the hip during Pavlik treatment. Bone Joint J. 2025 Jan 1;107-B(1):118-123. doi: 10.1302/0301-620X.107B1.BJJ-2024-0443.R1.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia Garisto contact
Luckshman Bavan principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pavlik Harness in people with Developmental Dysplasia of Hip and DDH, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luckshman Bavan (416-813-7654 ext. 415513, luckshman.bavan@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular Index at 24 Months of Age (time frame: At 24 months of age, with an allowable assessment window of ±3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07847619, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.