Assessing a Limited Ultrasound Protocol in DDH

NCT03608475 | Completed

• 1 other identifier: REB1000056980
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Complication Rate

  Through study completion, an average of two years

• Health Care Costs

  Through study completion, an average of two years

• Hospital Appointment Duration

  Through study completion, an average of two years

Study Arms (2)

Comprehensive Ultrasound Group

ACTIVE COMPARATOR

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

Limited Ultrasound Group

EXPERIMENTAL

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

Interventions

Limited Ultrasound Imaging OTHER

Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits

Limited Ultrasound Group

Standard Ultrasound Imaging OTHER

Ultrasound imaging will be performed at all clinic visits

Comprehensive Ultrasound Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V 1X8, Canada

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon P Kelley, PhD, FRCS

  The Hospital for Sick Children, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 1, 2018
• Study Start: July 27, 2018
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)