NCT07561697

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in ankle dorsiflexion

    Frequency of patients with improvement in ankle dorsiflexion will be noted.

    6 months

Secondary Outcomes (3)

  • Bleeding

    1 hour

  • Infection

    6 months

  • Incomplete tenotomy

    6 months

Study Arms (2)

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.

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.

Procedure: Tendo-Achilles Lengthening

Interventions

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.

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 Tendo-Achilles Lengthening technique.

Tendo-Achilles Lengthening-Group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Any gender
  • Aged 2-5 years
  • diagnosed with clubfoot
  • Pirani score 3-6

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pervez Ali, FCPS

    Jinnah Postgraduate Medical Centre, Karachi, Pakistan

    STUDY DIRECTOR
  • Sidratul Zaitoon

    Jinnah Postgraduate Medical Centre, Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pervez Ali, FCPS

CONTACT

Sidratul Zaitoon

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

August 15, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations