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

Comparison of Effectiveness of Surgical Blade No. 11 and Ophthalmic Knife for Percutaneous Achilles Tendon Tenotomy in Idiopathic Clubfoot Patients

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

Study Overview

• Status: Recruiting
• Conditions: Clubfoot
• Intervention / Treatment: Device: Surgical Blade; Device: Ophthalmic Knife

Detailed Description

Percutaneous Achilles tendon tenotomy is performed using surgical blade no. 11. However, concerns regarding incision size, bleeding, and scarring have led to exploration of alternative instruments. Previously, comparative studies have been conducted on a 22-gauge needle vs. a surgical blade. However, an ophthalmic knife, designed for microsurgical precision, offers a fine tip and elongated handle, allowing improved control during tendon release with a small incision and precision. Previous studies have compared blade and needle techniques and ophthalmic knives for percutaneous tenotomy of the Achilles tendon done on animals. The study findings would be helpful in opting for a better instrument for the procedure that should be effective and have a better safety profile.

• Study Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• 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

• Pakistan
  • 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
      • Sub-Investigator: Pervez Ali, FCPS
      • Principal Investigator: Sidratul Zaitoon
    • Karachi, Sindh, Pakistan, 75510
      • Completed
      • Jinnah Postgraduate Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11.
Group-B; Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife.	Device: Ophthalmic Knife; Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in ankle dorsiflexion	The frequency of patients will be noted who will have improved Pirani score.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	The frequency of patients will be noted who will have bleeding severity as none, mild, moderate, or excessive.	1 hour
Infection	The frequency of patients will be noted who will have infected wound.	3 months
Incomplete Tenotomy	Frequency of patients who will have incomplete release or residual deformity assessed after 3	3 months

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• 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

Study Major Dates

• Study Start (Actual): September 20, 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-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