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Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method

Primary Purpose

Clubfoot, Ponseti Method, Talipes Equinovarus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Plaster of Paris (POP) casting using the Ponseti Method
Semi-Rigid Fiberglass softcast using the Ponseti Method
Sponsored by
Alberta Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clubfoot

Eligibility Criteria

1 Week - 12 Weeks (Child)All Sexes

Inclusion Criteria:

  • congenital idiopathic clubfoot

Exclusion Criteria:

  • positional equinovarus
  • teratologic etiologies of clubfoot
  • treatment started at another center
  • refuse randomization
  • do not understand English

Sites / Locations

  • Alberta Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plaster of Paris (POP)

semi-rigid fiberglass softcast (SRF, 3M Scotchcast)

Arm Description

Outcomes

Primary Outcome Measures

number of casts required to correct the clubfoot deformities

Secondary Outcome Measures

need for percutaneous tendo-achilles tenotomy
total time in casts (weeks)
ease of cast removal
time of cast removal
method(s) of cast removal
other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

Full Information

First Posted
February 10, 2010
Last Updated
February 10, 2010
Sponsor
Alberta Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01067651
Brief Title
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
Official Title
Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alberta Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
Detailed Description
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clubfoot, Ponseti Method, Talipes Equinovarus, Casting

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Plaster of Paris (POP)
Arm Type
Active Comparator
Arm Title
semi-rigid fiberglass softcast (SRF, 3M Scotchcast)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Plaster of Paris (POP) casting using the Ponseti Method
Intervention Type
Device
Intervention Name(s)
Semi-Rigid Fiberglass softcast using the Ponseti Method
Primary Outcome Measure Information:
Title
number of casts required to correct the clubfoot deformities
Time Frame
time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved
Secondary Outcome Measure Information:
Title
need for percutaneous tendo-achilles tenotomy
Title
total time in casts (weeks)
Title
ease of cast removal
Title
time of cast removal
Time Frame
number of minutes required for each cast removal
Title
method(s) of cast removal
Title
other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
12 Weeks
Eligibility Criteria
Inclusion Criteria: congenital idiopathic clubfoot Exclusion Criteria: positional equinovarus teratologic etiologies of clubfoot treatment started at another center refuse randomization do not understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Howard, MD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada

12. IPD Sharing Statement

Citations:
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10934626
Citation
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Citation
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Results Reference
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Links:
URL
http://www.global-help.org
Description
Website provides links to the publication entitled: Clubfoot: Ponseti Management

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Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method

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