Clubfoot Tenotomy Trial

Completed · Phase 4 · Has a placebo group

Conditions studied: Clubfoot

In brief

Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is frequently performed in the office with a local anesthetic to avoid exposure to general anesthesia in the operating room. Topical anesthetic creams are commonly used to provide local analgesia for this procedure. The cream is applied to the infant's skin around the achilles tendon and requires 30 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. An alternative is a needle-free jet injection system that uses compressed CO2 to push 0.25 ml of lidocaine into the skin, providing local analgesia at the site of administration. This method likewise provides analgesia to the site of application at a depth of 5-8 mm, yet only takes approximately 1-2 minutes to achieve maximum effect. Aim 1: Determine which pain management method, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine), provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: Jet injection will provide equal or greater pain control when compared topical anesthetic cream. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine). Hypothesis: Jet injection of local anesthesia will not be associated with an increased rate of adverse events in comparison to topical anesthetic cream. If jet injection of local anesthesia is shown to provide comparable or better pain control without an increase in adverse events, use of this needle-free injection system will decrease the overall length of the procedure visit, thus increasing quality, safety, and value.

Key facts

Study ID

NCT04766684

Run by

Vanderbilt University Medical Center

People needed

107

Starts

2021-06-01

Expected to finish

2024-08-01

Last updated by the study team

2026-05-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clubfoot patients less than 6 weeks of age at start of casting
• Patients requiring in-office percutaneous achilles lengthening (TAL) following serial casting

You may not qualify if…

• 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

Where it is running

• Vanderbilt Children's Orthopaedics — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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