Trial Outcomes & Findings for Clubfoot Tenotomy Trial (NCT NCT04766684)
NCT ID: NCT04766684
Last Updated: 2026-05-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
FLACC Score at the time of tenotomy (poke of the scalpel)
Results posted on
2026-05-05
Participant Flow
Each site screened consecutive patients with presenting with foot deformity to the outpatient clinic. Infants with unilateral or bilateral idiopathic clubfoot aged 6 weeks or less were recruited to enroll in the study. Patients were excluded if there was previous clubfoot treatment, an underlying neuromuscular diagnosis such as spina bifida, or age greater than 6 weeks at the time of enrollment.
Patients enrolled in the study were treated with the Ponseti method. Weekly serial casting was initiated with above-knee Ponseti clubfoot casts. After the final weekly serial casting visit, the attending surgeon determined if the patient would need either unilateral or bilateral TAL due to residual equinus deformity. If tenotomy was not required, the patient was then transitioned to a foot abduction orthosis and removed from the study.
Participant milestones
| Measure |
Control Group: TOPICAL Anesthesia
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
49
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Control Group: TOPICAL Anesthesia
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
|---|---|---|
|
Overall Study
physician decision: tenotomy not needed
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
placebo cream unavailable due to supply issue
|
0
|
1
|
Baseline Characteristics
Clubfoot Tenotomy Trial
Baseline characteristics by cohort
| Measure |
Control Group: TOPICAL Anesthesia
n=49 Participants
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
n=45 Participants
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
49 Participants
n=54 Participants
|
45 Participants
n=60 Participants
|
94 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=54 Participants
|
16 Participants
n=60 Participants
|
37 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
57 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=54 Participants
|
28 Participants
n=60 Participants
|
67 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=54 Participants
|
14 Participants
n=60 Participants
|
19 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
20 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=54 Participants
|
33 Participants
n=60 Participants
|
72 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Unilateral vs. Bilateral Clubfoot Deformity
Unilateral
|
23 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
48 Participants
n=114 Participants
|
|
Unilateral vs. Bilateral Clubfoot Deformity
Bilateral
|
26 Participants
n=54 Participants
|
20 Participants
n=60 Participants
|
46 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group: TOPICAL Anesthesia
n=49 Participants
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
n=45 Participants
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
|---|---|---|
|
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
|
9.5 score on a scale (0-10)
Standard Deviation 1.2
|
8.4 score on a scale (0-10)
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Heart Rate at the time of tenotomy (poke of the scalpel)Heart Rate
Outcome measures
| Measure |
Control Group: TOPICAL Anesthesia
n=49 Participants
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
n=45 Participants
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
|---|---|---|
|
Heart Rate
|
204.1 Beats per minute
Standard Deviation 21.7
|
196.4 Beats per minute
Standard Deviation 24.1
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group: TOPICAL Anesthesia
n=49 Participants
Prior to the tenotomy procedure, the control group (TOPICAL) had 4% liposomal lidocaine cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of saline. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
Intervention Group: JET Anesthesia
n=45 Participants
Prior to the tenotomy procedure, the intervention group (JET) had placebo cream applied to the posterior heel of the affected side(s) and secured with a clear adhesive bandage. After at least 30 minutes, the cream was removed, and the heel was cleansed and prepped for the procedure. The location of the percutaneous tenotomy was marked and the skin was prepped. A jet injector (J-Tip, National Medical Products, Inc.) was then used to inject the tenotomy site(s) with 0.25ml of 1% lidocaine. After 3 minutes, the heel was prepped, and unilateral or bilateral percutaneous tenotomy was performed and above-knee Ponseti clubfoot cast(s) were applied.
|
|---|---|---|
|
Oxygen Saturation
|
94.9 percentage
Standard Deviation 5.7
|
94.4 percentage
Standard Deviation 6.9
|
Adverse Events
Control Group: TOPICAL Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group: JET Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey E. Martus, MD MS
Vanderbilt University Medical Center
Phone: 615-343-5875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place