ClubfootPhase 4ClubTTNCT04766684
Clubfoot Tenotomy Trial
A Phase 4 study testing Jet injection of 1% lidocaine and 4% liposomal lidocaine cream in people with Clubfoot, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Clubfoot
- What is being tested?
- Jet injection of 1% lidocaine and 4% liposomal lidocaine cream
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clubfoot patients less than 6 weeks of age at start of casting
- Patients requiring in-office percutaneous achilles lengthening (TAL) following serial casting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Orthopaedics
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Clubfoot
- Being tested
- Jet injection of 1% lidocaine, 4% liposomal lidocaine cream
- Keywords
- Clubfoot, J-Tip, Jet Injection, Local Anesthesia, Topical Anesthesia, Tenotomy, TAL, Achilles Lengthening, Pain Control
- Medical subject headings
- Clubfoot, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jet injection of 1% lidocaineDevice
Jet injection of 1% lidocaine
4% liposomal lidocaine creamDrug
4% liposomal lidocaine cream
| Study group | Role | What they receive |
|---|---|---|
| Placebo cream and jet injection of 0.25mL 1% lidocaine | Experimental | Not described Receives: Device: Jet injection of 1% lidocaine |
| 4% liposomal lidocaine cream and jet injection of 0.25 ml saline | Active comparator | Not described Receives: Drug: 4% liposomal lidocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: FLACC Score at the time of tenotomy (poke of the scalpel)
Heart Rate
Heart Rate
Measured: 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
Measured: Oxygen saturation at the time of tenotomy (poke of the scalpel)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jun 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Martus, Vanderbilt University Medical Center
- Investigators
- Jeffrey Martus, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766684
- Sponsor's protocol ID
- 200842
- Acronym
- ClubTT
- Status last verified
- May 2026
- First submitted
- 26 Jan 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not currently a plan to share IPD with other researchers.
Publications
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.
PubMed 12186603Spanos 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.
PubMed 18645542COMMITTEE 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.
PubMed 26810788Morcuende 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.
PubMed 14754952Lunoe 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.
PubMed 25935844Lebel 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.
PubMed 22584844Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21.
PubMed 12131451Ansar 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.
PubMed 29511012
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Local Anesthetic Options for Clubfoot Tenotomy: Needle-Free Jet Injection Versus Topical Cream
- ClinicalTrials.gov ID
- NCT04766684
- Acronym / sponsor ID
- ClubTT / 200842
- Conditions
- Clubfoot
- Keywords
- Clubfoot, J-Tip, Jet Injection, Local Anesthesia, Topical Anesthesia, Tenotomy, TAL, Achilles Lengthening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clubfoot patients less than 6 weeks of age at start of casting
- Patients requiring in-office percutaneous achilles lengthening (TAL) following serial casting
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jet injection of 1% lidocaineJet injection of 1% lidocaine | Device | Placebo cream and jet injection of 0.25mL 1% lidocaine |
| 4% liposomal lidocaine cream4% liposomal lidocaine cream | Drug | 4% liposomal lidocaine cream and jet injection of 0.25 ml saline |
Primary outcome
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
Heart Rate
Time frame: Heart Rate at the time of tenotomy (poke of the scalpel)
Heart Rate
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12186603Taddio 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.
- Background: PubMed 18645542Spanos 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.
- Background: PubMed 26810788COMMITTEE 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.
- Background: PubMed 14754952Morcuende 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.
- Background: PubMed 25935844Lunoe 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.
- Background: PubMed 22584844Lebel 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.
- Background: PubMed 12131451Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21.
- Background: PubMed 29511012Ansar 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.
- Individual participant dataSharing planned: No. There is not currently a plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Martus, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jet injection of 1% lidocaine and 4% liposomal lidocaine cream in people with Clubfoot, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC (Face, Legs, Activity, Cry, Consolability) Scale (time frame: FLACC Score at the time of tenotomy (poke of the scalpel)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766684, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.