Assessing a Limited Ultrasound Protocol in DDH

The Hospital for Sick Children

Status: Completed

Conditions: Developmental Dysplasia of the Hip

Treatments: Other: Standard Ultrasound Imaging; Other: Limited Ultrasound Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03608475

REB1000056980

Details and patient eligibility

About

Developmental Dysplasia of the Hip (DDH) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Initial data from our practice suggests that interim ultrasounds do not alter the course or outcome of treatment. Additionally, these ultrasounds add significant time to clinic visits and carry a substantial cost to the health care system. The goal of this study is to determine if limiting the number of ultrasounds during treatment results in the same outcomes while also evaluating the amount of time and money saved by omitting the ultrasounds.

Enrollment: 100 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 0-6 months at time of diagnosis
• Clinical and Ultrasound diagnosis of stable developmental dysplasia of the hip
• Children with dislocated/ unstable DDH will be included once the hip becomes stable
• Treated with Pavlik harness
• Assessed and treated at the SickKids Baby Hip Clinic

Exclusion criteria

• Underlying neuromuscular disease
• Teratologic hip dysplasia
• Prior treatment at other institutions
• Non-compliance with treatment protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Comprehensive Ultrasound Group

Active Comparator group

Description:

Children in the comprehensive ultrasound protocol group will follow the current standardized treatment protocol used at the Hospital for Sick Children in Toronto, Canada. For children presenting with stable hip dysplasia, Pavlik harness (PH) treatment is initiated at the initial visit (week 0) and runs for a total of 12 weeks. Children return to clinic at weeks 2, 5, 8 and 12 for clinical and ultrasound examinations to ensure that the harness is fitting correctly, to screen for PH complications and to monitor acetabular development.

Treatment:

Other: Standard Ultrasound Imaging

Limited Ultrasound Group

Experimental group

Description:

Children in the limited ultrasound protocol group will receive the same treatment as described for the comprehensive ultrasound group above, except the ultrasound imaging conducted at weeks 2, 5 and 8 will be omitted. Children will still return to clinic at 2, 5, and 8 weeks for clinical examination, which includes the assessment of the Pavlik harness fit and screening for complications.

Treatment:

Other: Limited Ultrasound Imaging