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Assessing a Limited Ultrasound Protocol in DDH

Primary Purpose

Developmental Dysplasia of the Hip

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Limited Ultrasound Imaging
Standard Ultrasound Imaging
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dysplasia of the Hip

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comprehensive Ultrasound Group

Limited Ultrasound Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acetabular Index
Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
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.

Secondary Outcome Measures

Complication Rate
The frequency of complications between the treatment groups will be compared
Health Care Costs
The difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds
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

Full Information

First Posted
June 20, 2018
Last Updated
June 8, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT03608475
Brief Title
Assessing a Limited Ultrasound Protocol in DDH
Official Title
A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dysplasia of the Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Ultrasound Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Limited Ultrasound Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Limited Ultrasound Imaging
Intervention Description
Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits
Intervention Type
Other
Intervention Name(s)
Standard Ultrasound Imaging
Intervention Description
Ultrasound imaging will be performed at all clinic visits
Primary Outcome Measure Information:
Title
Acetabular Index
Description
Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
Time Frame
When patient reaches 1 year of age
Title
International Hip Dysplasia Institute Score
Description
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.
Time Frame
When patient reaches 1 year of age
Secondary Outcome Measure Information:
Title
Complication Rate
Description
The frequency of complications between the treatment groups will be compared
Time Frame
Through study completion, an average of two years
Title
Health Care Costs
Description
The difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds
Time Frame
Through study completion, an average of two years
Title
Hospital Appointment Duration
Description
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
Time Frame
Through study completion, an average of two years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon P Kelley, PhD, FRCS
Organizational Affiliation
The Hospital for Sick Children, Toronto, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing a Limited Ultrasound Protocol in DDH

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