Assessing a Limited Ultrasound Protocol in DDH

Developmental Dysplasia of the Hip Clinical Trial

Official title:

A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608475
• Other study ID #: REB1000056980
• Status: Completed
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: May 10, 2022

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Intervention

Other:
• Limited Ultrasound Imaging
Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits
• Standard Ultrasound Imaging
Ultrasound imaging will be performed at all clinic visits

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular Index	Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis	When patient reaches 1 year of age
Primary	International Hip Dysplasia Institute Score	The International Hip Dysplasia Institute (IHDI) grade will be measured from a radiograph of the pelvis. The score classifies hips into one of four groups based on the position of the proximal femoral metaphysis in relation to the acetabulum. The scores grade severity from Grade 1 as the mildest type to Grade 4 as the most severe type of hip dislocation.	When patient reaches 1 year of age
Secondary	Complication Rate	The frequency of complications between the treatment groups will be compared	Through study completion, an average of two years
Secondary	Health Care Costs	The difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds	Through study completion, an average of two years
Secondary	Hospital Appointment Duration	Calculating time between registering at Ultrasound and registering at the Orthopaedic clinic will provide a measurement of time savings in the limited ultrasound protocol group	Through study completion, an average of two years