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Phase 4 N=107 Randomized Quadruple-blind Treatment

Clubfoot Tenotomy Trial

Clubfoot

Enrolled (actual)
107
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: FLACC (Face, Legs, Activity, Cry, Consolability) Scale — 9.5; 8.4 score on a scale (0-10)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Jet injection of 1% lidocaine (Device); 4% liposomal lidocaine cream (Drug)
Age
Pediatric
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
9.5; 8.4
PRIMARY
Heart Rate
204.1; 196.4
PRIMARY
Oxygen Saturation
94.9; 94.4

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04766684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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