CClinicalTrials.gg
CompletedNCT07561736Updated Jul 17, 2026

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

An observational study in Clubfoot, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Muhammad Aamir Latif · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
102
Ages
2 Years to 5 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Clubfoot

Browse trials for

03

In context

Clubfoot

79 studies on the registry are indexed under Clubfoot; 18 are open to participants now.

This study's enrollment of 102 is above the median of 55 across 29 observational studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children with other neuromuscular
  • Chromosomal abnormalities
  • Arthrogryposis multiplex congenita
  • Myelomeningocele
  • Dystrophic dysplasia
  • Moebius syndrome
  • Amniotic band syndrome
  • Metatarsus adductus
  • Syndactyly
  • Polydactyly
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • Group-A

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

    Device: Surgical Blade

  • Group-B

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

    Device: Ophthalmic Knife

Interventions

  • DeviceSurgical Blade

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

  • DeviceOphthalmic Knife

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

06

What researchers measure

Primary outcomes

  1. Improvement in ankle dorsiflexion

    Frequency of patients who had improved Pirani score was noted.

    Time frame: 3 months after surgery

Secondary outcomes

  1. Bleeding

    Frequencies of patients who had bleeding severity as none, mild, moderate, or excessive, were noted.

    Time frame: 1 hour after surgery

  2. Infection

    The frequency of patients who had infected wound was noted.

    Time frame: 3 months after surgery

  3. Incomplete Tenotomy

    Frequency of patients who had incomplete release or residual deformity was assessed.

    Time frame: 3 months after surgery

07

Study locations

1 site
  • Jinnah Postgraduate Medical Centre
    Karachi, Sindh 75510, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07561736
Lead sponsor
Muhammad Aamir Latif
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
May 1, 2026
Start date
Nov 1, 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Jul 17, 2026

Study contacts

Pervez Ali, FCPS
study director · Jinnah Postgraduate Medical Centre, Karachi, Pakistan
Sidratul Zaitoon
principal investigator · Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion