- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07561697
Percutaneous Achilles Tendon Tenotomy vs Tendo-Achilles Lengthening (TAL) in Neglected Clubfoot Children.
April 24, 2026 updated by: Muhammad Aamir Latif
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pervez Ali, FCPS
- Phone Number: +923333001737
- Email: pervez73@hotmail.com
Study Contact Backup
- Name: Sidratul Zaitoon
- Phone Number: +923150012163
- Email: sidra9503@gmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75510
- Recruiting
- Jinnah Postgraduate Medical Centre
-
Contact:
- Pervez Ali, FCPS
- Phone Number: +923333001737
- Email: pervez73@hotmail.com
-
Contact:
- Sidratul Zaitoon
- Phone Number: +923150012163
- Email: sidra9503@gmail.com
-
Principal Investigator:
- Sidratul Zaitoon
-
Sub-Investigator:
- Pervez Ali
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Any gender
- Aged 2-5 years
- diagnosed with clubfoot
- Pirani score 3-6
Exclusion Criteria:
- Patients with other neuromuscular, chromosomal abnormalities
- myelomeningocele
- Dystrophic dysplasia
- Moebius syndrome
- Amniotic band syndrome
- Metatarsus adductus
- Syndactyly
- Polydactyly
- Previously underwent Achilles tendon tenotomy or tendo-Achilles lengthening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in ankle dorsiflexion
Time Frame: 6 months
|
Frequency of patients with improvement in ankle dorsiflexion will be noted.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding
Time Frame: 1 hour
|
Frequencies of bleeding as none, mild moderate, and severe will be noted.
|
1 hour
|
|
Infection
Time Frame: 6 months
|
Frequency of patients who had an infected wound will be noted.
|
6 months
|
|
Incomplete tenotomy
Time Frame: 6 months
|
Frequency of patients who will have incomplete release or residual deformity assessed after 6 months.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pervez Ali, FCPS, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
- Principal Investigator: Sidratul Zaitoon, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2025
Primary Completion (Estimated)
April 30, 2026
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
April 24, 2026
First Submitted That Met QC Criteria
April 24, 2026
First Posted (Actual)
May 1, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 24, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Clubfoot
Other Study ID Numbers
- Dr-Pervez-Ali-Karachi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be shared on a reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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