Prospective Evaluation of Treatment for Clubfoot

Part of paid clinical trials in Dallas, Texas.

Sponsor
Texas Scottish Rite Hospital for Children
Study ID
NCT02257229
Status
Recruiting
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Conditions

  • Clubfoot Deformity

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 31, 2005
Status verified
Apr 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: Surgical
    Corrective Surgery only
  • Arm: Non-Surgical
    Correction with casting, braces, Physical therapy, other non-surgical methods
  • Arm: Non-surgical + surgical
    Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Scottish Rite Hospital for ChildrenDallasTexas75219
Rusty Hartman, MS
[email protected]
214-559-8371
Anthony I Riccio, MD (PRINCIPAL_INVESTIGATOR)

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Texas Scottish Rite Hospital for Children· Dallas, TX