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Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

Primary Purpose

Hip Dislocation, Congenital, Congenital Deformity of Hip Joint

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pavlik Brace

Plastizote Brace

About this trial

This is an interventional treatment trial for Hip Dislocation, Congenital

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

0-2 months of age
Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound

Exclusion Criteria:

Ages greater than 2 months
Neurological condition
Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
Chromosomal abnormality

Sites / Locations

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Plastizote Brace

Pavlik Brace

Arm Description

Outcomes

Primary Outcome Measures

Resolution of instability

Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Secondary Outcome Measures

Resolution of instability

Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Full Information

NCT ID

NCT01375218

First Posted

June 15, 2011

Last Updated

January 16, 2015

Sponsor

OrthoCarolina Research Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01375218

Brief Title

Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

Official Title

Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OrthoCarolina Research Institute, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.

6. Conditions and Keywords

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

Hip Dislocation, Congenital, Congenital Deformity of Hip Joint

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plastizote Brace

Arm Type

Active Comparator

Arm Title

Pavlik Brace

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Pavlik Brace

Intervention Description

Pavlik Brace

Intervention Type

Other

Intervention Name(s)

Plastizote Brace

Intervention Description

Plastizote Brace

Primary Outcome Measure Information:

Title

Resolution of instability

Description

Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Time Frame

3-4 week interval

Secondary Outcome Measure Information:

Title

Resolution of instability

Description

Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Time Frame

6 month interval

10. Eligibility

Sex

All

Maximum Age & Unit of Time

2 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 0-2 months of age Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound Exclusion Criteria: Ages greater than 2 months Neurological condition Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound Chromosomal abnormality

Facility Information:

Facility Name

OrthoCarolina Research Institute, OrthoCarolina, P.A.

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36214650

Citation

Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD012717. doi: 10.1002/14651858.CD012717.pub2.

Results Reference

derived

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Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

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