NCT01375218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 19, 2015

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

June 15, 2011

Last Update Submit

January 16, 2015

Conditions

Hip Dislocation, CongenitalCongenital Deformity of Hip Joint

Outcome Measures

Primary Outcomes (1)

  • Resolution of instability

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

    3-4 week interval

Secondary Outcomes (1)

  • Resolution of instability

    6 month interval

Study Arms (2)

Plastizote Brace

ACTIVE COMPARATOR
Other: Plastizote Brace

Pavlik Brace

ACTIVE COMPARATOR
Other: Pavlik Brace

Interventions

Pavlik BraceOTHER

Pavlik Brace

Pavlik Brace
Plastizote BraceOTHER

Plastizote Brace

Plastizote Brace

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Charlotte, North Carolina, 28209, United States

Location

Related Publications (1)

  • 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.

    PMID: 36214650DERIVED

MeSH Terms

Conditions

Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the HipMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 17, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 19, 2015

Record last verified: 2013-12

Locations

US(1)