ClubfootNCT07561697
Percutaneous Achilles Tendon Tenotomy vs Tendo-Achilles Lengthening (TAL) in Neglected Clubfoot Children.
An observational study of Clubfoot, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Achilles tendon tenotomy is the established worldwide gold standard for correcting idiopathic clubfoot. However, in neglected cases, surgical interventions such as percutaneous Achilles tendon tenotomy (PAT) and open tendo-Achilles lengthening (TAL) are common techniques for correcting this deformity. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Tenotomy of Achilles Tendon and Tendo-Achilles Lengthening
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2025to 30 Apr 2026
- Phase
- Observational
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Newly diagnosed patients of clubfoot between 2 and 5 years of age having Pirani score 3-6 within the study period will be recruited.
Who may be able to join
- Any gender
- Aged 2-5 years
- diagnosed with clubfoot
- Pirani score 3-6
Who cannot join
- Patients with other neuromuscular, chromosomal abnormalities
- myelomeningocele
- Dystrophic dysplasia
- Moebius syndrome
- Amniotic band syndrome
- Metatarsus adductus
Show all 9Show fewer
- Syndactyly
- Polydactyly
- Previously underwent Achilles tendon tenotomy or tendo-Achilles lengthening
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
Jinnah Postgraduate Medical Centre
Karachi, Sindh, 75510
Pervez Ali, FCPS, +923333001737, pervez73@hotmail.com
Sidratul Zaitoon, +923150012163, sidra9503@gmail.com
About this study
Official title: Functional Outcomes of Percutaneous Achilles Tendon Tenotomy vs Tendo-Achilles Lengthening (TAL) in Neglected Clubfoot Children Age 2-5 Years.
Achilles tendon tenotomy is the established worldwide gold standard for correcting idiopathic clubfoot. However, in neglected cases, surgical interventions such as percutaneous Achilles tendon tenotomy (PAT) and open tendo-Achilles lengthening (TAL) are common techniques for correcting this deformity. This study aimed at determining the functional outcomes of Percutaneous Achilles Tendon Tenotomy (PAT) vs tendo-Achilles Lengthening (TAL) in the neglected clubfoot children of age 2-5 years.
Read the detailed description
Despite the increasing use of percutaneous techniques, there is a lack of literature directly comparing the functional outcomes of these two procedures, PAT and TAL. Addressing this knowledge gap is essential to guide pediatric orthopedic surgeons in selecting the most appropriate intervention for the treatment of equinus deformity in neglected clubfoot patients, optimizing functional recovery, minimizing complications, and ultimately improving the quality of care for children with neglected clubfoot.
- Conditions
- Clubfoot
- Being tested
- Tenotomy of Achilles Tendon, Tendo-Achilles Lengthening
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenotomy of Achilles TendonProcedure or surgery
Patients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tenotomy of Achilles tendon technique.
Tendo-Achilles LengtheningProcedure or surgery
Patients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the Tendo-Achilles Lengthening technique.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Achilles Tendon Tenotomy-Group | Patients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tenotomy of Achilles tendon technique. Receives: Procedure: Tenotomy of Achilles Tendon | |
| Tendo-Achilles Lengthening-Group | Patients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tendo-Achilles Lengthening technique. Receives: Procedure: Tendo-Achilles Lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ankle dorsiflexion
Frequency of patients with improvement in ankle dorsiflexion will be noted.
Measured: 6 months
Secondary outcomes (3)
Bleeding
Frequencies of bleeding as none, mild moderate, and severe will be noted.
Measured: 1 hour
Infection
Frequency of patients who had an infected wound will be noted.
Measured: 6 months
Incomplete tenotomy
Frequency of patients who will have incomplete release or residual deformity assessed after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Aug 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Pervez Ali, FCPS, Study director, Jinnah Postgraduate Medical Centre, Karachi, PakistanSidratul Zaitoon, Principal investigator, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561697
- Sponsor's protocol ID
- Dr-Pervez-Ali-Karachi
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Percutaneous Achilles Tendon Tenotomy vs Tendo-Achilles Lengthening (TAL) in Neglected Clubfoot Children Age 2-5 Years.
- ClinicalTrials.gov ID
- NCT07561697
- Acronym / sponsor ID
- Dr-Pervez-Ali-Karachi
- Conditions
- Clubfoot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 May 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.
Achilles tendon tenotomy is the established worldwide gold standard for correcting idiopathic clubfoot. However, in neglected cases, surgical interventions such as percutaneous Achilles tendon tenotomy (PAT) and open tendo-Achilles lengthening (TAL) are common techniques for correcting this deformity. This study aimed at determining the functional outcomes of Percutaneous Achilles Tendon Tenotomy (PAT) vs tendo-Achilles Lengthening (TAL) in the neglected clubfoot children of age 2-5 years.
Detailed description
Despite the increasing use of percutaneous techniques, there is a lack of literature directly comparing the functional outcomes of these two procedures, PAT and TAL. Addressing this knowledge gap is essential to guide pediatric orthopedic surgeons in selecting the most appropriate intervention for the treatment of equinus deformity in neglected clubfoot patients, optimizing functional recovery, minimizing complications, and ultimately improving the quality of care for children with neglected clubfoot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Achilles Tendon Tenotomy-Group | – | Procedure: Tenotomy of Achilles TendonPatients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tenotomy of Achilles tendon technique. |
| Tendo-Achilles Lengthening-Group | – | Procedure: Tendo-Achilles LengtheningPatients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tendo-Achilles Lengthening technique. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newly diagnosed patients of clubfoot between 2 and 5 years of age having Pirani score 3-6 within the study period will be recruited.
Key inclusion criteria (4 listed)
- Any gender
- Aged 2-5 years
- diagnosed with clubfoot
- Pirani score 3-6
Key exclusion criteria (9 listed)
- Patients with other neuromuscular, chromosomal abnormalities
- myelomeningocele
- Dystrophic dysplasia
- Moebius syndrome
- Amniotic band syndrome
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 |
|---|---|---|
| Tenotomy of Achilles TendonPatients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the tenotomy of Achilles tendon technique. | Procedure or surgery | Percutaneous Achilles Tendon Tenotomy-Group |
| Tendo-Achilles LengtheningPatients will be started on serial casting and manipulation according to ponseti method. After successful correction of cavus, varus, and adductus, patients will be treated using the Tendo-Achilles Lengthening technique. | Procedure or surgery | Tendo-Achilles Lengthening-Group |
Primary outcome
Improvement in ankle dorsiflexion
Time frame: 6 months
Frequency of patients with improvement in ankle dorsiflexion will be noted.
3 secondary outcomes
Bleeding
Time frame: 1 hour
Infection
Time frame: 6 months
Incomplete tenotomy
Time frame: 6 months
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 1 May 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Pervez Ali, FCPS study director
Jinnah Postgraduate Medical Centre, Karachi, Pakistan
Sidratul Zaitoon principal investigator
Jinnah Postgraduate Medical Centre, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Muhammad Aamir Latif 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 4 inclusion and 9 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 1 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 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 Pervez Ali, FCPS (+923333001737, pervez73@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in ankle dorsiflexion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.