Comparison of No. 11 Surgical Blade and Ophthalmic Knife for Achilles Tenotomy in Children with Clubfoot
Comparison of Effectiveness of Surgical Blade No. 11 and Ophthalmic Knife for Percutaneous Achilles Tendon Tenotomy in Idiopathic Clubfoot Patients
This will test whether using an ophthalmic knife or the standard No. 11 surgical blade gives better results for percutaneous Achilles tendon tenotomy in children aged 2–5 with idiopathic clubfoot.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | RESnTEC, Institute of Research Academic / other |
| Locations | 2 sites (Karachi, Sindh and 1 other locations) |
| Trial ID | NCT07561736 on ClinicalTrials.gov |
What this trial studies
This observational comparison follows children with idiopathic clubfoot who undergo percutaneous Achilles tendon tenotomy performed with either a No. 11 surgical blade or an ophthalmic knife. The study records procedural details such as incision size, bleeding, ease of tendon release, and short-term wound outcomes to compare safety and effectiveness. Previously published work has compared blades with needles and explored ophthalmic knives in animal models, but direct human comparisons of these two instruments are limited. Findings aim to inform clinicians about which instrument may offer finer control and fewer local complications.
Who should consider this trial
Good fit: Children aged 2–5 years with idiopathic clubfoot who are scheduled for percutaneous Achilles tendon tenotomy and do not meet any exclusion criteria are ideal candidates.
Not a fit: Children with syndromic or neuromuscular forms of clubfoot, other listed congenital disorders, or those outside the 2–5 year age range are unlikely to benefit from these specific comparisons.
Why it matters
Potential benefit: If successful, the findings could help surgeons choose an instrument that reduces incision size, bleeding, and scarring while improving control during tenotomy in young children.
How similar studies have performed: Prior studies have compared blade versus needle techniques and tested ophthalmic knives in animal models, but direct human comparisons of the No. 11 blade and ophthalmic knife are limited, making this a relatively novel comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Karachi, Sindh and 1 other locations
- Jinnah Postgraduate Medical Centre — Karachi, Sindh, Pakistan (Completed)
- Jinnah Postgraduate Medical Centre — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Sidratul Zaitoon — Jinnah Postgraduate Medical Centre, Karachi, Pakistan
- Study coordinator: Pervez Ali, FCPS
- Email: pervez73@hotmail.com
- Phone: +923333001737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.