Clubfoot Tenotomy Trial (ClubTT)

May 1, 2026 updated by: Jeffrey Martus, Vanderbilt University Medical Center

A Randomized Comparison of Local Anesthetic Options for Clubfoot Tenotomy: Needle-Free Jet Injection Versus Topical Cream

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clubfoot is a common congenital birth deformity, with a prevalence of approximately 1 in 1000 live births. Without treatment, clubfoot can cause significant disability. Percutaneous tendoachilles lengthening (TAL) is commonly required to correct residual equinus deformity during the Ponseti method. TAL may be performed in the operating room under general anesthesia or in outpatient settings using local anesthesia, but evidence guiding optimal anesthetic strategies for in office procedures remains limited.

Effective pain control in infancy is critical. Experimental and clinical studies demonstrate that repeated early life painful stimuli lead to hyperinnervation, heightened sensitivity, altered stress responses, and lower pain thresholds later in life. Cumulative procedural pain is associated with poorer cognitive and developmental outcomes and early interventions to reduce pain lessen cortisol exposure and improve neurobehavioral trajectories. Poorly controlled pain during neonatal or early childhood procedures has also been linked to altered pain behaviors during later procedures, emphasizing the long lasting impact of early nociceptive experiences.

Existing approaches for in office TAL include needle infiltration of local anesthetic or application of topical anesthetic cream. Needle infiltration may create soft tissue swelling that obscures the tenotomy site and increases procedural difficulty, and both techniques have been associated with substantial infant distress despite adequate application.

Needle free jet injection offers a potential alternative. Prior studies demonstrate that jet injection produces less pain than conventional needle infiltration and provides superior analgesia to topical anesthetics for procedures such as venipuncture, intravenous catheter placement, and lumbar puncture.

The Clubfoot Tenotomy Trial (ClubTT) was designed to evaluate whether jet injected local anesthesia provides equivalent analgesic efficacy without increasing adverse events compared with topical anesthesia for infants with idiopathic clubfoot undergoing in office TAL.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Children's Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo cream and jet injection of 0.25mL 1% lidocaine
Device: Jet injection of 1% lidocaine
Jet injection of 1% lidocaine
Active Comparator: 4% liposomal lidocaine cream and jet injection of 0.25 ml saline
Drug: 4% liposomal lidocaine cream
4% liposomal lidocaine cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
Time Frame: FLACC Score at the time of tenotomy (poke of the scalpel)
The FLACC scale is used to assess pain in children. For this study, it will be administered by the Certified Child Life Specialist. The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain in children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent reduced pain on the scale
FLACC Score at the time of tenotomy (poke of the scalpel)
Heart Rate
Time Frame: Heart Rate at the time of tenotomy (poke of the scalpel)
Heart Rate
Heart Rate at the time of tenotomy (poke of the scalpel)
Oxygen Saturation
Time Frame: Oxygen saturation at the time of tenotomy (poke of the scalpel)
Pulse oximetry will be used to measure oxygen levels in the blood. An oxygen saturation level of 95 percent is considered normal
Oxygen saturation at the time of tenotomy (poke of the scalpel)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Jeffrey Martus, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not currently a plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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