Comparison of Surgical Blade No. 11 and Ophthalmic Knife in Idiopathic Clubfoot Patients

NCT07561736 | Recruiting

• 1 other identifier: Dr-Pervez-Karachi
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. 11 and ophthalmic knife for percutaneous Achilles tendon tenotomy in Idiopathic clubfoot patients

Conditions

Clubfoot

Outcome Measures

Primary Outcomes (1)

• Improvement in ankle dorsiflexion

  The frequency of patients will be noted who will have improved Pirani score.

  3 months

Secondary Outcomes (3)

• Bleeding

  1 hour

• Infection

  3 months

• Incomplete Tenotomy

  3 months

Study Arms (2)

Group-A

Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11.

Device: Surgical Blade

Group-B

Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife.

Device: Ophthalmic Knife

Interventions

Surgical Blade DEVICE

Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11.

Group-A

Ophthalmic Knife DEVICE

Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife.

Group-B

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients of clubfoot less than 6 months of age and having the Pirani score 3-6 within the study period were recruited.

You may qualify if:

• Any gender
• Aged 2-5 years
• Diagnosed with clubfoot

You may not qualify if:

• Children with other neuromuscular
• Chromosomal abnormalities
• Arthrogryposis multiplex congenita
• Myelomeningocele
• Dystrophic dysplasia
• Moebius syndrome
• Amniotic band syndrome
• Metatarsus adductus
• Syndactyly
• Polydactyly

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (2)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

COMPLETED

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, 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

+923333001737; pervez73@hotmail.com

Sidratul Zaitoon

CONTACT

+923150012163; sidra9503@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• 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: September 20, 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

Locations

PA (2)