8 vs 12 Weeks: A Pavlik Harness Trial

NCT07847619 | Not Yet Recruiting

• 1 other identifier: 4266
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; 8 weeks; 12 weeks; developmental dysplasia of the hip

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• Caregiver-Reported Experience Measured Using the EMBRACE Tool

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Device: Pavlik Harness

Interventions

Pavlik Harness DEVICE

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.

12-Week Arm; 8-Week Arm

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (5)

• 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.

  PMID: 36047018 BACKGROUND

• Upasani 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.

  PMID: 35200217 BACKGROUND

• Kelley 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.

  PMID: 32043064 BACKGROUND

• Bradley 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.

  PMID: 37524345 BACKGROUND

• Bavan 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.

  PMID: 39740689 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Luckshman Bavan

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luckshman Bavan

CONTACT

416-813-7654; luckshman.bavan@sickkids.ca

Olivia Garisto

CONTACT

olivia.garisto@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Orthopaedic Surgeon, Division of Orthopaedic Surgery, The Hospital for Sick Children

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)