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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07561736

Enrollment

102

Registered

2026-05-01

Start date

2025-11-01

Completion date

2026-06-30

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clubfoot

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

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.

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Pakistan

Contacts

STUDY_DIRECTORPervez Ali, FCPS

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

PRINCIPAL_INVESTIGATORSidratul Zaitoon