Assessing a Limited Ultrasound Protocol in DDH

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

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.

Study Overview

• Status: Completed
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Other: Standard Ultrasound Imaging; Other: Limited Ultrasound Imaging

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comprehensive Ultrasound Group; 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.	Other: Standard Ultrasound Imaging; Ultrasound imaging will be performed at all clinic visits
Experimental: Limited Ultrasound Group; 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.	Other: Limited Ultrasound Imaging; Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular Index	Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis	When patient reaches 1 year of age
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rate	The frequency of complications between the treatment groups will be compared	Through study completion, an average of two years
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
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Simon P Kelley, PhD, FRCS, The Hospital for Sick Children, Toronto, Ontario, Canada

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: REB1000056980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No