Club FootNCT07554092
Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot
A study testing Ponseti Casting and Accelerated Ponseti Casting in people with Club Foot, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
Club foot (congenital talipes equinovarus) is a common birth deformity affecting 1-2 per 1,000 live births, with even higher rates in low-income countries. The standard treatment is the Ponseti method using weekly serial casts, but weekly visits for several weeks can be challenging for families in hot climates or with… Read more about this study
- Who is it for?
- Ages 1 day to 5 months
- Conditions the study is for
- Club Foot
- What is being tested?
- Ponseti Casting and Accelerated Ponseti Casting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Both gender with idiopathic club foot with age less than 6 months
Who cannot join
- Syndromic club foot (e.g., associated with arthrogryposis, myelomeningocele, or other genetic syndromes)
- Previous treatment for club foot (either serial casting or surgical intervention)
- Any other significant congenital anomaly or medical condition that, in the opinion of the investigator, would interfere with treatment or follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber Teaching Hospital
Peshawar, KPK, 25000
Dr Sikandar Hayat, MBBS, 92 332 9474849, drsikandar68@gmail.com
Dr Khalid Rehman, MBBS, +92 333 9432032 ext. Ali Naqvi, drkhalidrehman@kmu.edu.pk
About this study
Official title: Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot: Randomized Controlled Trial
Club foot (congenital talipes equinovarus) is a common birth deformity affecting 1-2 per 1,000 live births, with even higher rates in low-income countries. The standard treatment is the Ponseti method using weekly serial casts, but weekly visits for several weeks can be challenging for families in hot climates or with limited resources. This randomized controlled trial compares the standard once-weekly Ponseti casting with an accelerated twice-weekly casting technique. The primary outcome is radiological correction measured by the lateral talocalcaneal angle (target ≥35°) on standardized foot X-rays taken six weeks after brace fitting. Secondary outcomes include the talocalcaneal index (>40) and the tibio-calcaneal (dorsiflexion) angle (60-90°). Babies under six months of age with idiopathic club foot will be randomly assigned to either the standard or accelerated casting group. All other aspects of the Ponseti method (manipulation, number of casts, tenotomy when needed, final cast for three weeks, and foot abduction orthosis) remain identical. Adverse events such as skin problems, swelling, or cast complications will be recorded. The study aims to determine whether accelerated casting achieves better radiographic correction without increasing risks.
Read the detailed description
This open-label randomized controlled trial will be conducted at the dedicated Ponseti clinic, Department of Orthopedic and Trauma, Khyber Teaching Hospital, Peshawar, Pakistan, over six months. A total of 158 club feet (105 infants) with idiopathic club foot aged <6 months will be enrolled using non-probability consecutive sampling. After informed consent and baseline X-ray, participants are randomly allocated (sealed envelope, odd/even numbers from OpenEpi) to either standard once-weekly casting (every Monday) or accelerated twice-weekly casting (Monday and Friday). All other Ponseti protocol elements (manipulation, number of casts, tendo Achillis tenotomy when indicated, final cast for 3 weeks, and foot abduction orthosis) are identical. The primary outcome is lateral talocalcaneal angle (mean of dorsiflexion and plantar flexion views) ≥35° on standardized X-ray six weeks after bracing. Secondary outcomes are talocalcaneal index >40 and tibio-calcaneal angle 60-90°. Adverse events (skin sores, swelling, cast issues) are recorded. Allocation concealment is blinded to investigator and parents; the outcome assessor (pediatric orthopaedic fellow) is blinded to group assignment. Data will be analyzed using SPSS v20 (intention-to-treat, independent t-test or Mann-Whitney U, adjusted odds ratios, p<0.05 significant). Ethical approval will be obtained from Khyber Medical College, KMU, and ASRB. Treatment is free, but no financial compensation is provided.
- Conditions
- Club Foot
- Being tested
- Ponseti Casting, Accelerated Ponseti Casting
- Keywords
- Club Foot, Ponseti Casting Technique, Randomized controlled trial, Congenital talipes equinovarus
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponseti CastingProcedure or surgery
Also called Serial casting, Ponseti method, Ponseti technique
Participants receive serial manipulation and plaster cast application according to the standard Ponseti technique to correct clubfoot deformity (cavus, adduction, varus, and equinus). A long-leg plaster cast is applied after each manipulation session. Casts are changed either once weekly (every Monday) for the standard group or twice weekly (Monday and Friday) for the accelerated group. Typically 5 to 6 casts are required over the treatment course. When all deformities except equinus are corrected, a percutaneous tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn continuously for three weeks. After final cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for the first three months, then nights only until the child reaches five years of age. Radiological outcome is assessed six weeks after brace fitting.
Accelerated Ponseti CastingProcedure or surgery
erial manipulation and long-leg plaster cast applied twice every week (every Monday and Friday) until clubfoot correction is achieved. Typically 5-6 casts are applied over 2.5-3 weeks. This is the only difference compared to the standard arm. Tenotomy is performed under local anesthesia in the clinic when residual equinus remains after serial casting. A tenotomy knife is used to transect the Achilles tendon percutaneously, followed by a final cast for 3 weeks. This procedure is identical in both study arms.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ponseti Casting (Once Weekly) | Experimental | Participants in this arm receive standard Ponseti serial casting once per week (every Monday) until clubfoot correction is achieved. Each casting session includes manipulation followed by application of a plaster cast. Typically 5 to 6 casts are required. When indicated, a tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn for three weeks. After cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for three months, then nights only until five years of age. Radiological outcome is assessed six weeks after brace fitting. Receives: Procedure: Ponseti Casting |
| Accelerated Ponseti Casting (Twice Weekly) | Active comparator | Participants in this arm receive accelerated Ponseti serial casting twice per week (every Monday and Friday) until clubfoot correction is achieved. All other elements are identical to the standard arm: manipulation technique, number of casts (typically 5-6), tendo Achillis tenotomy under local anesthesia when indicated, a final cast for three weeks, followed by the same foot abduction orthosis (Miracle Feet brace) with identical wearing schedule. Radiological outcome is assessed six weeks after brace fitting. The only difference from the standard arm is the frequency of cast changes. Receives: Procedure: Accelerated Ponseti Casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Talocalcaneal Angle (TCA-Lat)
The lateral talocalcaneal angle measured on standardized lateral foot X-ray. The angle is calculated as the mean of measurements taken in both dorsiflexion and plantar flexion views. A value of 35 degrees or above indicates successful correction of hindfoot varus. The measurement will be performed by a pediatric orthopaedic fellow blinded to treatment group assignment.
Measured: 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Feb 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Club FootStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model comparing two groups: standard once-weekly Ponseti casting versus accelerated twice-weekly Ponseti casting.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery, Principal investigator, Khyber Medical University PeshawarDr Khalid Rehman, MBBS, Principal investigator, Institute of Public Health & Social Science, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554092
- Sponsor's protocol ID
- KMU/DIR/CTU/2026/001
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication (including de-identified radiological measurements, Pirani scores, adverse event data, and baseline demographics) will be shared upon reasonable request for the purpose of meta-analysis or independent verification. No identifiable information (names, contact details, photographs) will be shared.
Publications
Cady R, Hennessey TA, Schwend RM. Diagnosis and Treatment of Idiopathic Congenital Clubfoot. Pediatrics. 2022 Feb 1;149(2):e2021055555. doi: 10.1542/peds.2021-055555.
PubMed 35104362Bridgens J, Kiely N. Current management of clubfoot (congenital talipes equinovarus). BMJ. 2010 Feb 2;340:c355. doi: 10.1136/bmj.c355. No abstract available.
PubMed 20124368Ponseti IV, Smoley EN. The classic: congenital club foot: the results of treatment. 1963. Clin Orthop Relat Res. 2009 May;467(5):1133-45. doi: 10.1007/s11999-009-0720-2. Epub 2009 Feb 14.
PubMed 19219519Zimmerman CC, Nemeth BA, Noonan KJ, Vanderbilt TP, Winston MJ, O'Halloran CP, Sund SA, Hetzel SJ, Halanski MA. Reliability of radiographic measures in infants with clubfoot treated with the Ponseti method. J Child Orthop. 2015 Apr;9(2):99-104. doi: 10.1007/s11832-015-0647-y. Epub 2015 Mar 17.
PubMed 25777178Shaheen S, Jaiballa H, Pirani S. Interobserver reliability in Pirani clubfoot severity scoring between a paediatric orthopaedic surgeon and a physiotherapy assistant. J Pediatr Orthop B. 2012 Jul;21(4):366-8. doi: 10.1097/BPB.0b013e3283514183.
PubMed 22343939
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07554092
- Acronym / sponsor ID
- KMU/DIR/CTU/2026/001
- Conditions
- Club Foot
- Keywords
- Club Foot, Ponseti Casting Technique, Randomized controlled trial, Congenital talipes equinovarus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Club foot (congenital talipes equinovarus) is a common birth deformity affecting 1-2 per 1,000 live births, with even higher rates in low-income countries. The standard treatment is the Ponseti method using weekly serial casts, but weekly visits for several weeks can be challenging for families in hot climates or with limited resources. This randomized controlled trial compares the standard once-weekly Ponseti casting with an accelerated twice-weekly casting technique. The primary outcome is radiological correction measured by the lateral talocalcaneal angle (target ≥35°) on standardized foot X-rays taken six weeks after brace fitting. Secondary outcomes include the talocalcaneal index (>40) and the tibio-calcaneal (dorsiflexion) angle (60-90°). Babies under six months of age with idiopathic club foot will be randomly assigned to either the standard or accelerated casting group. All other aspects of the Ponseti method (manipulation, number of casts, tenotomy when needed, final cast for three weeks, and foot abduction orthosis) remain identical. Adverse events such as skin problems, swelling, or cast complications will be recorded. The study aims to determine whether accelerated casting achieves better radiographic correction without increasing risks.
Detailed description
This open-label randomized controlled trial will be conducted at the dedicated Ponseti clinic, Department of Orthopedic and Trauma, Khyber Teaching Hospital, Peshawar, Pakistan, over six months. A total of 158 club feet (105 infants) with idiopathic club foot aged <6 months will be enrolled using non-probability consecutive sampling. After informed consent and baseline X-ray, participants are randomly allocated (sealed envelope, odd/even numbers from OpenEpi) to either standard once-weekly casting (every Monday) or accelerated twice-weekly casting (Monday and Friday). All other Ponseti protocol elements (manipulation, number of casts, tendo Achillis tenotomy when indicated, final cast for 3 weeks, and foot abduction orthosis) are identical. The primary outcome is lateral talocalcaneal angle (mean of dorsiflexion and plantar flexion views) ≥35° on standardized X-ray six weeks after bracing. Secondary outcomes are talocalcaneal index >40 and tibio-calcaneal angle 60-90°. Adverse events (skin sores, swelling, cast issues) are recorded. Allocation concealment is blinded to investigator and parents; the outcome assessor (pediatric orthopaedic fellow) is blinded to group assignment. Data will be analyzed using SPSS v20 (intention-to-treat, independent t-test or Mann-Whitney U, adjusted odds ratios, p<0.05 significant). Ethical approval will be obtained from Khyber Medical College, KMU, and ASRB. Treatment is free, but no financial compensation is provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model comparing two groups: standard once-weekly Ponseti casting versus accelerated twice-weekly Ponseti casting.
| Arm | Type | Receives |
|---|---|---|
| Standard Ponseti Casting (Once Weekly) | Experimental | Procedure: Ponseti CastingParticipants in this arm receive standard Ponseti serial casting once per week (every Monday) until clubfoot correction is achieved. Each casting session includes manipulation followed by application of a plaster cast. Typically 5 to 6 casts are required. When indicated, a tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn for three weeks. After cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for three months, then nights only until five years of age. Radiological outcome is assessed six weeks after brace fitting. |
| Accelerated Ponseti Casting (Twice Weekly) | Active comparator | Procedure: Accelerated Ponseti CastingParticipants in this arm receive accelerated Ponseti serial casting twice per week (every Monday and Friday) until clubfoot correction is achieved. All other elements are identical to the standard arm: manipulation technique, number of casts (typically 5-6), tendo Achillis tenotomy under local anesthesia when indicated, a final cast for three weeks, followed by the same foot abduction orthosis (Miracle Feet brace) with identical wearing schedule. Radiological outcome is assessed six weeks after brace fitting. The only difference from the standard arm is the frequency of cast changes. |
Who may qualify
- Ages
- 1 day to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Both gender with idiopathic club foot with age less than 6 months
Key exclusion criteria (3 listed)
- Syndromic club foot (e.g., associated with arthrogryposis, myelomeningocele, or other genetic syndromes)
- Previous treatment for club foot (either serial casting or surgical intervention)
- Any other significant congenital anomaly or medical condition that, in the opinion of the investigator, would interfere with treatment or follow-up
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 |
|---|---|---|
| Ponseti CastingAlso: Serial casting, Ponseti method, Ponseti techniqueParticipants receive serial manipulation and plaster cast application according to the standard Ponseti technique to correct clubfoot deformity (cavus, adduction, varus, and equinus). A long-leg plaster cast is applied after each manipulation session. Casts are changed either once weekly (every Monday) for the standard group or twice weekly (Monday and Friday) for the accelerated group. Typically 5 to 6 casts are required over the treatment course. When all deformities except equinus are corrected, a percutaneous tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn continuously for three weeks. After final cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for the first three months, then nights only until the child reaches five years of age. Radiological outcome is assessed six weeks after brace fitting. | Procedure or surgery | Standard Ponseti Casting (Once Weekly) |
| Accelerated Ponseti Castingerial manipulation and long-leg plaster cast applied twice every week (every Monday and Friday) until clubfoot correction is achieved. Typically 5-6 casts are applied over 2.5-3 weeks. This is the only difference compared to the standard arm. Tenotomy is performed under local anesthesia in the clinic when residual equinus remains after serial casting. A tenotomy knife is used to transect the Achilles tendon percutaneously, followed by a final cast for 3 weeks. This procedure is identical in both study arms. | Procedure or surgery | Accelerated Ponseti Casting (Twice Weekly) |
Primary outcome
Lateral Talocalcaneal Angle (TCA-Lat)
Time frame: 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)
The lateral talocalcaneal angle measured on standardized lateral foot X-ray. The angle is calculated as the mean of measurements taken in both dorsiflexion and plantar flexion views. A value of 35 degrees or above indicates successful correction of hindfoot varus. The measurement will be performed by a pediatric orthopaedic fellow blinded to treatment group assignment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 35104362Cady R, Hennessey TA, Schwend RM. Diagnosis and Treatment of Idiopathic Congenital Clubfoot. Pediatrics. 2022 Feb 1;149(2):e2021055555. doi: 10.1542/peds.2021-055555.
- Background: PubMed 20124368Bridgens J, Kiely N. Current management of clubfoot (congenital talipes equinovarus). BMJ. 2010 Feb 2;340:c355. doi: 10.1136/bmj.c355. No abstract available.
- Background: PubMed 19219519Ponseti IV, Smoley EN. The classic: congenital club foot: the results of treatment. 1963. Clin Orthop Relat Res. 2009 May;467(5):1133-45. doi: 10.1007/s11999-009-0720-2. Epub 2009 Feb 14.
- Background: PubMed 25777178Zimmerman CC, Nemeth BA, Noonan KJ, Vanderbilt TP, Winston MJ, O'Halloran CP, Sund SA, Hetzel SJ, Halanski MA. Reliability of radiographic measures in infants with clubfoot treated with the Ponseti method. J Child Orthop. 2015 Apr;9(2):99-104. doi: 10.1007/s11832-015-0647-y. Epub 2015 Mar 17.
- Background: PubMed 22343939Shaheen S, Jaiballa H, Pirani S. Interobserver reliability in Pirani clubfoot severity scoring between a paediatric orthopaedic surgeon and a physiotherapy assistant. J Pediatr Orthop B. 2012 Jul;21(4):366-8. doi: 10.1097/BPB.0b013e3283514183.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication (including de-identified radiological measurements, Pirani scores, adverse event data, and baseline demographics) will be shared upon reasonable request for the purpose of meta-analysis or independent verification. No identifiable information (names, contact details, photographs) will be shared.
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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.
Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery principal investigator
Khyber Medical University Peshawar
Dr Khalid Rehman, MBBS principal investigator
Institute of Public Health & Social Science, Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ponseti Casting and Accelerated Ponseti Casting in people with Club Foot, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Apr 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery (03329474849, drsikandar68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral Talocalcaneal Angle (TCA-Lat) (time frame: 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)). 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 NCT07554092, which also lists 5 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 28 Apr 2026.