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Assessing a Limited Ultrasound Protocol in DDH

NCT ID: NCT03608475

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2022-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Developmental Dysplasia of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard Ultrasound Imaging

Intervention Type OTHER

Ultrasound imaging will be performed at all clinic visits

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.

Group Type EXPERIMENTAL

Limited Ultrasound Imaging

Intervention Type OTHER

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

Interventions

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Limited Ultrasound Imaging

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

Intervention Type OTHER

Standard Ultrasound Imaging

Ultrasound imaging will be performed at all clinic visits

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Simon Kelley

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon P Kelley, PhD, FRCS

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Ontario, Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB1000056980

Identifier Type: -

Identifier Source: org_study_id