Clubfoot Tenotomy Trial

NCT04766684 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 200842
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clubfoot

Keywords

Clubfoot; J-Tip; Jet Injection; Local Anesthesia; Topical Anesthesia; Tenotomy; TAL; Achilles Lengthening; Pain Control

Outcome Measures

Primary Outcomes (3)

• FLACC (Face, Legs, Activity, Cry, Consolability) Scale

  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

  Heart Rate

  Heart Rate at the time of tenotomy (poke of the scalpel)

• Oxygen Saturation

  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)

Study Arms (2)

Placebo cream and jet injection of 0.25mL 1% lidocaine

EXPERIMENTAL

Device: Jet injection of 1% lidocaine

4% liposomal lidocaine cream and jet injection of 0.25 ml saline

ACTIVE COMPARATOR

Drug: 4% liposomal lidocaine cream

Interventions

Jet injection of 1% lidocaine DEVICE

Jet injection of 1% lidocaine

Placebo cream and jet injection of 0.25mL 1% lidocaine

4% liposomal lidocaine cream DRUG

4% liposomal lidocaine cream

4% liposomal lidocaine cream and jet injection of 0.25 ml saline

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Children's Orthopaedics

Nashville, Tennessee, 37232, United States

Location

Related Publications (8)

• Taddio A, Shah V, Gilbert-MacLeod C, Katz J. Conditioning and hyperalgesia in newborns exposed to repeated heel lances. JAMA. 2002 Aug 21;288(7):857-61. doi: 10.1001/jama.288.7.857.

  PMID: 12186603 BACKGROUND

• Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b.

  PMID: 18645542 BACKGROUND

• COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.

  PMID: 26810788 BACKGROUND

• Morcuende JA, Dolan LA, Dietz FR, Ponseti IV. Radical reduction in the rate of extensive corrective surgery for clubfoot using the Ponseti method. Pediatrics. 2004 Feb;113(2):376-80. doi: 10.1542/peds.113.2.376.

  PMID: 14754952 BACKGROUND

• Lunoe MM, Drendel AL, Levas MN, Weisman SJ, Dasgupta M, Hoffmann RG, Brousseau DC. A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children. Ann Emerg Med. 2015 Nov;66(5):466-74. doi: 10.1016/j.annemergmed.2015.04.003. Epub 2015 Apr 29.

  PMID: 25935844 BACKGROUND

• Lebel E, Karasik M, Bernstein-Weyel M, Mishukov Y, Peyser A. Achilles tenotomy as an office procedure: safety and efficacy as part of the Ponseti serial casting protocol for clubfoot. J Pediatr Orthop. 2012 Jun;32(4):412-5. doi: 10.1097/BPO.0b013e31825611a6.

  PMID: 22584844 BACKGROUND

• Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21.

  PMID: 12131451 BACKGROUND

• Ansar A, Rahman AE, Romero L, Haider MR, Rahman MM, Moinuddin M, Siddique MAB, Mamun MA, Mazumder T, Pirani SP, Mathias RG, Arifeen SE, Hoque DME. Systematic review and meta-analysis of global birth prevalence of clubfoot: a study protocol. BMJ Open. 2018 Mar 6;8(3):e019246. doi: 10.1136/bmjopen-2017-019246.

  PMID: 29511012 BACKGROUND

MeSH Terms

Conditions

Clubfoot; Agnosia

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A principal limitation is that infants cannot directly report pain during the tenotomy, requiring reliance on surrogate markers-such as heart rate, oxygen saturation, and FLACC behavioral scores-to estimate pain severity. Additionally, individual variability in responses to painful stimuli may not be fully captured by temperament assessments or baseline surrogate measures.

Results Point of Contact

• Title: Jeffrey E. Martus, MD MS
• Organization: Vanderbilt University Medical Center

jeff.martus@vumc.org

615-343-5875

Study Officials

• Jeffrey Martus, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On the day of or after the final casting visit, the participant will be randomized in equal proportion (1:1) to either the control group (4% liposomal lidocaine cream with saline jet injection) or the intervention group (placebo cream with 1% lidocaine jet injection). Participants, care providers, investigators, and outcome assessors will be blinded to the randomization groups. An outside pharmacy, the Health \& Wellness Compounding Pharmacy, will provide and blind the 4% liposomal lidocaine and placebo creams. The Vanderbilt Investigational Drug Service will provide the blinded 1% lidocaine and saline vials for jet injection. The Investigational Drug Service will store the creams provided by the outside pharmacy and the jet injection vials. They will assist in dispensing the creams/vials to the outpatient clinic.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 23, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)