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Completed

NCT Number: NCT07561736

Comparison of Surgical Blade No. 11 and Ophthalmic Knife 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

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Key information

Conditions

Clubfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Blade

Device

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

Ophthalmic Knife

Device

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

Primary outcomes

  1. Improvement in ankle dorsiflexion

    Time frame: 3 months after surgery

    Frequency of patients who had improved Pirani score was noted.

Secondary outcomes

  1. Bleeding

    Time frame: 1 hour after surgery

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

  2. Infection

    Time frame: 3 months after surgery

    The frequency of patients who had infected wound was noted.

  3. Incomplete Tenotomy

    Time frame: 3 months after surgery

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

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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