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

July 15, 2026 updated by: Muhammad Aamir Latif

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Jinnah Postgraduate Medical Centre

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 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

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
Group-A
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11.
Device: Surgical Blade
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11.
Group-B
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife.
Device: Ophthalmic Knife
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in ankle dorsiflexion
Time Frame: 3 months after surgery
Frequency of patients who had improved Pirani score was noted.
3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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)

November 1, 2025

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

June 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)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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