Status:
ACTIVE_NOT_RECRUITING
Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Clubfoot
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE4
Brief Summary
Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in the office with a ...
Detailed Description
Clubfoot is a common congenital birth deformity, with a prevalence of 1 in 1000 live births. If left untreated, clubfoot can cause significant disability. Treatment of clubfoot has evolved over severa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Clubfoot patients less than 6 weeks of age at start of casting
- Patients presenting to Vanderbilt DOT 4 Clinic for care
- Patients undergoing in-clinic Achilles Tenotomy
- Exclusion Criteria
- Clubfoot patients greater than 6 weeks of age at the start of casting
- Previous clubfoot treatment
- Patients with a neuromuscular condition (spina bifida, caudal regression syndrome, arthrogryposis, etc.)
- In-office TAL is not recommended by treating physician due to patient factors such as age or size
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04766684
Start Date
June 1 2021
End Date
January 1 2026
Last Update
June 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt Children's Orthopaedics
Nashville, Tennessee, United States, 37232