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OpenTrials
Completed

NCT Number: NCT03608475

Assessing a Limited Ultrasound Protocol in DDH

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.

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Key information

Conditions

Developmental Dysplasia of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limited Ultrasound Imaging

Other

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

Standard Ultrasound Imaging

Other

Ultrasound imaging will be performed at all clinic visits

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2018
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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