Assessing a Limited Ultrasound Protocol in DDH

• ClinicalTrials.gov Identifier: NCT03608475
• Recruitment Status: Recruiting
• First Posted: August 1, 2018
• Last Update Posted: February 17, 2021
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Simon Kelley, The Hospital for Sick Children

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Developmental Dysplasia of the Hip	Other: Limited Ultrasound Imaging; Other: Standard Ultrasound Imaging	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip
• Actual Study Start Date: July 27, 2018
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Acetabular Index [ Time Frame: When patient reaches 1 year of age ]
   Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
2. International Hip Dysplasia Institute Score [ Time Frame: When patient reaches 1 year of age ]
   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.

Secondary Outcome Measures :

1. Complication Rate [ Time Frame: Through study completion, an average of two years ]
   The frequency of complications between the treatment groups will be compared
2. Health Care Costs [ Time Frame: Through study completion, an average of two years ]
   The difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds
3. Hospital Appointment Duration [ Time Frame: Through study completion, an average of two years ]
   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

Eligibility Criteria

• Ages Eligible for Study: up to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Simon P Kelley, PhD, FRCS; (416) 813-6435; simon.kelley@sickkids.ca

Locations

Canada, Ontario

The Hospital for Sick Children; Recruiting

Toronto, Ontario, Canada, M5V 1X8

Contact: Simon Kelley

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

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

More Information

• Responsible Party: Simon Kelley, Orthopaedic Surgeon, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT03608475
• Other Study ID Numbers: REB1000056980
• First Posted: August 1, 2018
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities