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Recruiting NCT02257229

Prospective Evaluation of Treatment for Clubfoot

— Observational Clubfoot Deformity

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical, Non-Surgical, Non-surgical + surgical.
Who it may be relevant to
Registry conditions: Clubfoot Deformity. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Specific aim: To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

Detailed description

PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

Interventions

  • Procedure Surgical
    Surgery only
  • Procedure Non-Surgical
    non-surgical methods such as, casting, bracing, physical therapy, and other.
  • Procedure Non-surgical + surgical
    Combination of non-surgical methods subsequently followed by surgery

Primary outcome measures

  • Degree of correction at initial brace wear [Time frame: 2 months]

Eligibility criteria

Inclusion criteria

  • Patients with a diagnosis of clubfoot deformity
  • Spanish speaking patients will be eligible to participate in the study.

Exclusion criteria

  • All patients without a diagnosis of clubfoot

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Texas Scottish Rite Hospital for Children — Dallas

Identifiers

NCT: NCT02257229 · 032011-131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗